BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DURASAFE¿ TRAY

    MDR report key: 15670721 · Received October 25, 2022

    Report

    Report Number
    3014704491-2022-00520
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    July 20, 2020
    Report Date
    November 18, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    CAZ
    UDI-DI
    00382904016227
    PMA / PMN Number
    K012584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 05-NOV-2022. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9102592. 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. ADDITIONALLY, SAMPLES HAVE BEEN RECEIVED BY OUR FACILITY FOR THIS COMPLAINT. OUR ENGINEERS HAVE REVIEWED THE RETURNED UNITS AND FOUND A TEAR IN THE PACKAGING BAG, AND AN INTACT SEAL ALONG THE INTENDED TEARING POSITION. THE ISSUE HAS BEEN CONFIRMED. CLOSER ANALYSIS OF THE BAG WAS ABLE TO IDENTIFY CHARACTERISTIC MARKINGS ON THE BAG THAT INDICATE THAT AN EXTERNAL FORCE WAS APPLIED TO THE PACKAGING SOMETIME AFTER MANUFACTURING. BASED ON THIS OBSERVATION OUR ENGINEERS WERE NOT ABLE TO ASSOCIATE THE ROOT CAUSE FOR THIS EVENT THIS EVENT WITH THE PACKAGING PROCESS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. 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 · 0

    IT WAS REPORTED THAT LEAKAGE WAS FOUND COMING FROM THE BD DURASAFE¿ TRAY UNIT PACKAGING AFTER UNPACKING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "IN THE DEPARTMENT OF ANESTHESIOLOGY, THE PACKAGE LEAKED AFTER UNPACKING AND COULD NOT BE USED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE WAS FOUND COMING FROM THE BD DURASAFE¿ TRAY UNIT PACKAGING AFTER UNPACKING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "IN THE DEPARTMENT OF ANESTHESIOLOGY, THE PACKAGE LEAKED AFTER UNPACKING AND COULD NOT BE USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573092 BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT CAZ BD (SUZHOU) 9102592 00382904016227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown