BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE VENTED NOKOR 16X1 TW

    MDR report key: 10961875 · Received December 7, 2020

    Report

    Report Number
    1911916-2020-01102
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 9, 2020
    Report Date
    November 20, 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 · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305213 AND LOT NUMBER 0143230. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS THE NEEDLE ASSEMBLY WITH PLASTIC FLASH AT THE BOTTOM PART OF THE NEEDLE HUB. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR IF ONE OF THE MOLD CAVITIES HAD AN ISSUE THAT WAS NOT DETECTED DURING THE MOLDING INSPECTIONS OR IN THE NEXT PROCESSES. RATIONALE: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE VENTED NOKOR 16X1 TW HAD FOREIGN MATTER ON THE NEEDLE. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305213 BATCH NO.: 0143230. IT WAS REPORTED THAT FLASHING WAS OBSERVED ON THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428802 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