BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DURASAFE¿ TRAY

    MDR report key: 12636835 · Received October 14, 2021

    Report

    Report Number
    3014704491-2021-00199
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 15, 2021
    Report Date
    November 28, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    CAZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H6: INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9232404. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EPIDURAL CATHETER COULD NOT CONNECT TO THE DAMAGED BD DURASAFE¿ TRAY ADAPTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE PATIENT ENTERED THE OPERATING ROOM FOR NORMAL ANESTHESIA AND PUNCTURE CATHETERIZATION. AFTER CATHETERIZATION, IT WAS FOUND THAT THE EPIDURAL CATHETER COULD NOT BE CONNECTED TO THE CONNECTOR, SO HE HAD TO ABANDON THIS OPERATION AND REPLACE THE PUNCTURE KIT FOR A SECOND TIME. IT DOES NOT CAUSE THE DOCTOR'S WORK EXTENSIVELY, AND AT THE SAME TIME CAUSES SECONDARY INJURY TO THE PATIENT, AND ALSO INCREASES THE RISK OF SECONDARY INJURY AND MEDICAL DISPUTES"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EPIDURAL CATHETER COULD NOT CONNECT TO THE DAMAGED BD DURASAFE¿ TRAY ADAPTER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE PATIENT ENTERED THE OPERATING ROOM FOR NORMAL ANESTHESIA AND PUNCTURE CATHETERIZATION. AFTER CATHETERIZATION, IT WAS FOUND THAT THE EPIDURAL CATHETER COULD NOT BE CONNECTED TO THE CONNECTOR, SO HE HAD TO ABANDON THIS OPERATION AND REPLACE THE PUNCTURE KIT FOR A SECOND TIME. IT DOES NOT CAUSE THE DOCTOR'S WORK EXTENSIVELY, AND AT THE SAME TIME CAUSES SECONDARY INJURY TO THE PATIENT, AND ALSO INCREASES THE RISK OF SECONDARY INJURY AND MEDICAL DISPUTES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533431 BD DURASAFE¿ TRAY ANESTHESIA CONDUCTION KIT CAZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 9232404

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown