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    BD Contact Information: BD Global Product Incident Report (Pir) Form 1501-092-011-R

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    rsuerto
    A customer reported an issue with a BD product to BD. The report details the product name, lot number, quantity involved, and current location of the devices. It describes the specific incident, including where and when the problem occurred, what happened versus what was expected, and whether any patients were involved. The report asks whether the incident involved death, serious injury, erroneous results, exposure to blood or bodily fluids, or a safety issue with the device.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    BD Contact Information: BD Global Product Incident Report (Pir) Form 1501-092-011-R

    Uploaded by

    rsuerto
    23 views2 pages
    A customer reported an issue with a BD product to BD. The report details the product name, lot number, quantity involved, and current location of the devices. It describes the specific incident, including where and when the problem occurred, what happened versus what was expected, and whether any patients were involved. The report asks whether the incident involved death, serious injury, erroneous results, exposure to blood or bodily fluids, or a safety issue with the device.

    Original Title

    BD-Global-Product-Incident-Report

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    A customer reported an issue with a BD product to BD. The report details the product name, lot number, quantity involved, and current location of the devices. It describes the specific incident, including where and when the problem occurred, what happened versus what was expected, and whether any patients were involved. The report asks whether the incident involved death, serious injury, erroneous results, exposure to blood or bodily fluids, or a safety issue with the device.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    23 views2 pages

    BD Contact Information: BD Global Product Incident Report (Pir) Form 1501-092-011-R

    Uploaded by

    rsuerto
    A customer reported an issue with a BD product to BD. The report details the product name, lot number, quantity involved, and current location of the devices. It describes the specific incident, including where and when the problem occurred, what happened versus what was expected, and whether any patients were involved. The report asks whether the incident involved death, serious injury, erroneous results, exposure to blood or bodily fluids, or a safety issue with the device.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    BD GLOBAL PRODUCT INCIDENT REPORT (PIR) FORM

    1501-092-011-R

    1. BD Contact Information
    Email
    Employee Name
    (For Internal Use Only)
    Phone

    2. Customer Information
    Reporter Name/Title

    Facility name

    Address

    City/Region/State/Post Code/ Country

    Country Event Occurred

    Phone/Email

    Report received by
    Phone Email Other Specify:
    (For Internal Use Only)

    3. Product Details
    Product name

    Lot number(s) and/or Serial number(s)

    Material/Catalog Number

    Quantity Involved Contaminated? Yes No

    Used product available to be returned for evaluation No Yes How many units?

    Unused devices from the same lot number available


    N/A No Yes How many units?
    for evaluation (representative samples)

    Other location
    Current location of device(s) End user Distributor Destroyed
    Specify:

    Replacement 4. Incident Date (DD/


    Replacement or MM/YYYY)
    Credits for affected
    devices? 5. BD Awareness Date (DD/
    (For Internal Use Only) Credit MM/YYYY)
    (For Internal Use Only)

    Once completed, this document is considered a record that must be stored in


    accordance with company procedures.
    This document contains confidential, proprietary information of BD or one of its subsidiaries. It may not be copied or reproduced without Page
    prior written permission from BD. 1 of 2
    BD GLOBAL PRODUCT INCIDENT REPORT (PIR) FORM
    1501-092-011-R

    6. Description
    INFORMATION: Give specific and objective details of feedback or event. Include copies of all relevant correspondence, photographs etc.
    Where/When does the problem occur? Physical location of defect on the device, Step in the Process/Procedure, What Happened vs Expected? Was there any
    patient/end user involvement? Was the intent of the process/procedure changed?)
    I.e. The needle was clogged and the user was unable to administer insulin. However, the patient was able to administer the insulin with a second needle.

    How often has the defect occurred? Once Several times How many times? Whole batch

    7. Adverse Event Questions


    When did the incident occur? Before Use During Use After Use Unknown

    No Yes Date: Time:

    Death? Detailed Death Description:

    Unknown

    Serious Injury Unknown No Yes Description:

    Erroneous Results Unknown No Yes Description:

    Course of treatment changed due to event


    Include any alternate testing provided relative to Unknown No Yes Description:
    the change in treatment

    Exposure to Blood/Bodily Fluid


    Include exposure of toxic medication to skin and Unknown No Yes Description:
    list the specific medication that leaked. Indicate if
    exposure to mucosal membrane occurred

    Medical int. other than first aid


    X‐ray, CT Scan, MRI, Ultrasound, delay or change
    Unknown No Yes Description:
    in treatment/diagnosis, administration of
    antibiotics, surgical removal of a cannula, and etc.

    Needle/Probe Stick Unknown No Yes Description:

    Safety Issue
    Retraction failures, shielding failures, safety Unknown No Yes Description:
    feature failed to cover the needle properly.
    Indicate whether the feature failed prior to use

    Other actions taken


    Test or admin of medication (drugs/solutions) due
    to over or under dosage, imaging studies, admin of Description:
    Unknown No Yes
    prophylactic/antibiotics, blood transfusion ,admin
    of antivirals due to needle stick, post lab testing,
    hospitalization

    Once completed, this document is considered a record that must be stored in


    accordance with company procedures.
    This document contains confidential, proprietary information of BD or one of its subsidiaries. It may not be copied or reproduced without Page
    prior written permission from BD. 2 of 2

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