BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SPINAL¿ NEEDLE

    MDR report key: 7936230 · Received October 4, 2018

    Report

    Report Number
    3003152976-2018-00424
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 11, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    BSP
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SAMPLE UNIT WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON EXAMINATION OF THE SAMPLE, THE NEEDLE HUB WAS OBSERVED BROKEN. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY ISSUES DURING THE PRODUCTION OF PROVIDED LOT NUMBER: 1803001 THAT COULD HAVE CONTRIBUTED TO THE BROKEN PRODUCT. BASED ON THE INVESTIGATION, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT. IT IS POSSIBLE THAT THE DAMAGED PRODUCT RESULTED FROM A JAM WITHIN THE MANUFACTURING LINE, BUT THAT CANNOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SPINAL¿ NEEDLE HAD A SPIT NEEDLE HUB. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SPINAL¿ NEEDLE HAD A SPIT NEEDLE HUB. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777443 BD SPINAL¿ NEEDLE SPINAL NEEDLE BSP BECTON DICKINSON, S.A. 1803001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other