BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE VENTED NOKOR 16X1 TW

    MDR report key: 10865146 · Received November 18, 2020

    Report

    Report Number
    1911916-2020-01044
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 21, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052134
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 143230. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, THE SAMPLES FROM A SIMILAR COMPLAINT WERE USED IN THE INVESTIGATION. ONE PHOTO WAS PROVIDED. THE PHOTO SHOWS A NEEDLE ASSEMBLY WITH PLASTIC FLASH AT THE BOTTOM PART OF THE PLASTIC NEEDLE HUB. ADDITIONALLY, 1000 SAMPLES WERE RECEIVED AND THE SAMPLES CAME IN 10 SHELF BOXES OF 100 EACH. A VISUAL INSPECTION WAS PERFORMED, THE NEEDLE HUB FLASH WAS CONFIRMED. THE CAUSE FOR THIS DEFECT COULD HAVE RESULTED FROM AN ISSUE FROM THE MOLD THE MOLD AND THE DEFECTIVE SAMPLE WAS NOT DETECTED DURING THE MOLDING INSPECTIONS AND THE NEXT PROCESSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE VENTED NOKOR 16X1 TW HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305213 BATCH NO.: 0143230 IT WAS REPORTED THAT THERE WAS FLASHING AND ANGEL HAIR.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE VENTED NOKOR 16X1 TW HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305213 BATCH NO.: 0143230. IT WAS REPORTED THAT THERE WAS FLASHING AND ANGEL HAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330568 NEEDLE VENTED NOKOR 16X1 TW MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305213 0143230 00382903052134

    Patients

    Seq Age Sex Outcome Treatment
    1