BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET

    MDR report key: 8287179 · Received January 29, 2019

    Report

    Report Number
    3006948883-2019-00111
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Date of Event
    January 8, 2019
    Report Date
    March 8, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    CAZ
    UDI-DI
    00382904016227
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8103004, 8103006, AND 8138084. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN ANY OF THESE PRODUCTION BATCHS. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, CLEARLY DISPLAYING THE REPORTED FAILUE MODE. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED WITHOUT THE RETURN OF THE AFFECTED DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET WAS FOUND TO HAVE THE GREEN PART OF THE CONNECTOR CRACKED. THERE ARE SEVEN CONNECTOR WITH CRACKS.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8103004, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-04-13. MEDICAL DEVICE LOT #: 8103006, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-04-13. MEDICAL DEVICE LOT #: 8138084, MEDICAL DEVICE EXPIRATION DATE: 2023-05-31, DEVICE MANUFACTURE DATE: 2018-05-18. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET WAS FOUND TO HAVE THE GREEN PART OF THE CONNECTOR CRACKED. THERE ARE SEVEN CONNECTOR WITH CRACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79093 BD DURASAFE PLUS¿ EPIDURAL LOCK CSE NEEDLE SET EPIDURAL KIT CAZ BD (SUZHOU) SEE H.10 00382904016227

    Patients

    Seq Age Sex Outcome Treatment
    1 Other