BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PERISAFE¿ EPIDURAL ANAESTHESIA KITS

    MDR report key: 13442144 · Received February 3, 2022

    Report

    Report Number
    3014704491-2022-00056
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 19, 2022
    Report Date
    May 8, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    CAZ
    PMA / PMN Number
    K953790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0232885. 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, PHOTOGRAPHS OF THE AFFECTED DEVICE WERE SUBMITTED TO AID IN OUR INVESTIGATION. OUR ENGINEERS WERE ABLE TO IDENTIFY DAMAGE TO THE CATHETER TUBING HAD RESULTED IN A SHORTENED LENGTH. THE ISSUE HAS BEEN CONFIRMED. UNFORTUNATELY WITHOUT THE ABILITY TO REVIEW THE BROKEN EDGE OF THE CATHETER OUR ENGINEERS WERE NOT ABLE TO DETERMINE THE ROOT CAUSE FOR THIS EVENT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PERISAFE¿ EPIDURAL ANAESTHESIA KITS HAD THE NEEDLE BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EPIDURAL NEEDLE IS BROKEN WHILE WITHDRAWING FROM PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PERISAFE¿ EPIDURAL ANAESTHESIA KITS HAD THE NEEDLE BREAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE EPIDURAL NEEDLE IS BROKEN WHILE WITHDRAWING FROM PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779768 BD PERISAFE¿ EPIDURAL ANAESTHESIA KITS ANESTHESIA CONDUCTION KIT CAZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0232885

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown