BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE VENTED NOKOR 16X1 TW

    MDR report key: 10825033 · Received November 11, 2020

    Report

    Report Number
    1911916-2020-01023
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 30, 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 ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE INDUCED THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE THOUSAND PHYSICAL SAMPLES WERE RECEIVED. THEY CAME IN TEN SHELF BOXES WITH ONE HUNDRED SAMPLES EACH. VISUAL INSPECTION WAS PERFORMED, THE NEEDLE HUB FLASH WAS CONFIRMED AND NO OTHER DEFECT WAS OBSERVED. 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 AND THE NEXT PROCESSES. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINTS OF THIS PRODUCT AND LOT. IT COULD BE POSSIBLE ONE OF THE CAVITIES OF THE MOLD HAD AN ISSUE AND WAS NOT DETECTED DURING THE MOLDING INSPECTIONS AND THE NEXT PROCESSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE VENTED NOKOR 16X1 TW EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305213 BATCH NO.: 0143230. WE RECEIVED AGAIN A REJECTION FOR THIS PART: PO (B)(4) (REPLACEMENT ORDER) - PART# 5032A (305213) - R094420 ¿ LOT# 0143230 REASON: FLASHING AND ANGEL HAIR. ALL THE 5 SHIPMENTS RECEIVED HAD TO BE RETURNED TO THIS MATTER AND THIS IS A DIFFERENT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286018 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