BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRN ADAPTER

    MDR report key: 19519541 · Received June 12, 2024

    Report

    Report Number
    3002601200-2024-00247
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 16, 2024
    Report Date
    May 22, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3052879. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRN ADAPTER LEAKED (B)(6) 2024 WHILE USING THIS SINGLE-USE HEPARIN CAP, THE WARD NURSE NOTICED FLUID LEAKING FROM THE INTERFACE OF THIS HEPARIN CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189775 BD PRN ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BD SUZHOU (MDS) 3052879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown