BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DURASAFE¿ TRAY

    MDR report key: 15678836 · Received October 27, 2022

    Report

    Report Number
    3014704491-2022-00525
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    December 7, 2021
    Report Date
    November 20, 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

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1070521. 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, THREE SAMPLES HAVE BEEN RECEIVED BY OUR FACILITY FOR THIS COMPLAINT. OUR ENGINEERS HAVE SUBJECTED THE RETURNED DEVICE TO FUNCTIONAL TESTING FOR FLOW RATE. ONLY ONE DEVICE WAS A FOUND TO BE CLOGGED. THE ISSUE HAS BEEN CONFIRMED. CLOSER INSPECTION OF THE AFFECTED UNIT WAS ABLE TO LOCATE A DRIED MEDICINAL LIQUID BLOCKING THE FLOW CHANNEL. AFTER REMOVING THIS MATERIAL THE DEVICE WAS RETESTED FOR FLOW RATE CONFORMANCE AND WAS FOUND TO BE FREE OF ANY ADDITIONAL OBSTRUCTIONS. BASED ON THE RESULTS OUR ENGINEERS BELIEVE THE ROOT CAUSE FOR THIS EVENT IS RELATED TO THE INTERACTION OF THE MEDICAL SOLUTION BEING INFUSED INTO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DURASAFE¿ TRAY NEEDLE WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "IN THE DEPARTMENT OF ANESTHESIOLOGY, IT WAS FOUND THAT THE BLOCKED TUBE COULD NOT BE USED IN THE PROCESS OF USE, AND IT WAS FOUND THAT IT COULD NOT BE CLAMPED AND USED"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DURASAFE¿ TRAY NEEDLE WAS BLOCKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "IN THE DEPARTMENT OF ANESTHESIOLOGY, IT WAS FOUND THAT THE BLOCKED TUBE COULD NOT BE USED IN THE PROCESS OF USE, AND IT WAS FOUND THAT IT COULD NOT BE CLAMPED AND USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385359 BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT CAZ BD (SUZHOU) 1070521 00382904016227

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown