BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DURASAFE¿ TRAY

    MDR report key: 12256557 · Received July 30, 2021

    Report

    Report Number
    3006948883-2021-00855
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    May 11, 2021
    Report Date
    September 1, 2021
    Product Code
    CAZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0220527. 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 THE NEEDLE IN THE BD DURASAFE¿ TRAY WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE MEDICAL STAFF OPENED THE DISPOSABLE ANESTHESIA PUNCTURE PACKAGE AND FOUND THAT THE NEEDLE WAS DAMAGED. THEY SUSPECTED THE QUALITY OF THE PRODUCT, SO THEY STOPPED USING IT".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE IN THE BD DURASAFE¿ TRAY WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE MEDICAL STAFF OPENED THE DISPOSABLE ANESTHESIA PUNCTURE PACKAGE AND FOUND THAT THE NEEDLE WAS DAMAGED. THEY SUSPECTED THE QUALITY OF THE PRODUCT, SO THEY STOPPED USING IT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149154 BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT CAZ 0220527

    Patients

    Seq Age Sex Outcome Treatment
    1