BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS BL 22GA X 0.75IN QSYTE NON-PVC

    MDR report key: 19056905 · Received April 7, 2024

    Report

    Report Number
    3002601200-2024-00122
    Event Type
    Malfunction
    Date Received
    April 7, 2024
    Date of Event
    November 20, 2023
    Report Date
    April 5, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    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 3170879. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. 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 PEGASUS BL 22GA X 0.75IN QSYTE NON-PVC ADAPTER / CONNECTOR DEFECTIVE / DAMAGED - MFG CN SUZHOU 1 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHILE DEFLATING AN INDWELLING NEEDLE AND ADMINISTERING A SHOT, NOTICES THAT THE INDWELLING NEEDLE INFUSION CONNECTOR IS NOT WORKING AND IMMEDIATELY REPLACES THE INDWELLING NEEDLE TO COMPLETE THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329733 BD PEGASUS BL 22GA X 0.75IN QSYTE NON-PVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3170879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown