BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 10317938 · Received July 23, 2020

    Report

    Report Number
    1911916-2020-00681
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 10, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED AND EVALUATED. IT SHOWS A NEEDLE ASSEMBLY; THE PLASTIC NEEDLE HUB HAS A SHORT SHOT AT THE BASE. DURING THE PLASTIC NEEDLE HUB MOLDING PROCESS, A SHORT SHOT INDUCED THE DEFECT REPORTED BY THE CUSTOMER. BASED ON THE INVESTIGATION AND THE PHOTO PROVIDED, THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THIS IS THE 1ST COMPLAINT FOR LOT # 7200897 FOR THIS TYPE OF DEFECT OR SYMPTOM. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR THE ASSOCIATED ASSEMBLY BATCHES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: THIS IS THE 1ST COMPLAINT FOR LOT # 7200897 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH. ROOT CAUSE DESCRIPTION: DURING THE PLASTIC NEEDLE HUB MOLDING PROCESS A SHORT SHOT INDUCED THE DEFECT REPORTED BY THE CUSTOMER. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE 30X1/2 RB EXPERIENCED A CRACKED/DAMAGED HUB WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR CLINICAL SITES HAS RAISED A COMPLAINT REGARDING BD PRECISIONCLIDE NEEDLE 70G REF 305106, LOT: 7200897. THE NEEDLE GUARD HAS BEEN DAMAGED AND HAD TO BE DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782265 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 7200897 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other