BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 12519002 · Received September 23, 2021

    Report

    Report Number
    1911916-2021-01019
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 26, 2021
    Report Date
    September 10, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051069
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 20 AUGUST, 2021. MEDWATCH REPORT # MW5103133. REPORT SOURCE OTHER: MEDWATCH REPORT. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305106 AND LOT NUMBER 0072057. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. INVESTIGATION CONCLUSION: 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: BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB NEEDLE AND SYRINGE SEPARATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 30GAUGE X1/2IN BD NEEDLE WOULD NOT STAY ON THE SYRINGE. PER COMPLAINT DETAILS RECEIVED: THE 30GAUGE X1/2IN BD NEEDLE WOULD NOT STAY ON THE BD 1ML SLIP TIP TUBERCULIN SYRINGE. IT WAS REPORTED THAT THE UPON TRYING TO REMOVE THE CAP. THE WHOLE NEEDLE CAME OFF THE SLIP TIP. IT WAS REPORTED THAT THE FRICTION FOR THE HUB OF THE NEEDLE TO THE SYRINGE WAS LACKING. FDA SAFETY REPORT ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417858 NEEDLE 30X1/2 RB PISTON SYRINGE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0072057 00382903051069

    Patients

    Seq Age Sex Outcome Treatment
    1