BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 21403343 · Received February 18, 2025

    Report

    Report Number
    1710034-2025-00239
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 27, 2025
    Report Date
    March 19, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810345
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL LOT NUMBERS WERE PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 381034. LOT # 4239978 MNF DATE 2024-08-28 EXP DATE 2027-07-31. LOT # 4199766 MNF DATE 2024-07-25 EXP DATE 2027-06-30. LOT # 3362802 MNF DATE 2024-01-02 EXP DATE 2026-12-31. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE WOULD NOT RETRACT COULD NOT BE CONFIRMED FROM THE 4 REPRESENTATIVE 20G INSYTE AUTOGUARD UNITS THAT WERE RECEIVED IN SEALED UNIT PACKAGES FROM LOT 4239978. NO SAMPLES PHYSICAL SAMPLES WERE RECEIVED FOR BATCHES 4199766, 3362802, AND 4030760. A FUNCTIONAL TEST SHOWED THAT EACH NEEDLE RETRACTED WITHIN SPECIFICATION. NO DAMAGE OR DEFECTS WERE IDENTIFIED ON THE RETURNED SAMPLES. ALTHOUGH THE REPRESENTATIVE SAMPLES DO NOT SUPPORT THE COMPLAINANT¿S DESCRIPTION, THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE STATING CANNULA WAS NOT RETRACTING WHEN BUTTON PRESSED, TRIED MULTIPLE CANNULA'S WITH THE. LOT: 4239978 FOR SAME ISSUES. TRIED NEW LOT: 4199766 SAME ISSUES WOULD NOT RETRACT. TRIED LOT: 3362802. WOULD NOT RETRACT AS WELL. TRIED LOT 4030760, WOULD ALSO NOT RETRACT RIGHT AWAY. IT APPEARS AS IF BUTTON IS GETTING STUCK. MULTIPLE STAFF TRIED WAS NOT USER ERROR. ALL CANNULA'S REMOVED FROM FLOOR AND SENT TO MATERIALS MANAGEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572841 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4030760 00382903810345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown