BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 26X1/2 RB

    MDR report key: 10659831 · Received October 9, 2020

    Report

    Report Number
    1911916-2020-00950
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 28, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051114
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. 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 LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 26X1/2 RB NEEDLE BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305111 BATCH NO: UNKNOWN (REPORTED 191130). IT WAS REPORTED THAT THE NEEDLE BROKE INSIDE THE SEPTUM. EVENT DESCRIPTION PER EMAIL STATES: CALLER REPORTED THEY BROKE OFF THE NEEDLE FROM THE SYRINGE INSIDE OF THE SEPTUM AND NEEDLE BROKE OFF INTO CARTRIDGE. NUMBER OF OCCURRENCES: 1. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO. IS PRODUCT MANUFACTURED BY BD? YES, SAMPLE IS NOT AVAILABLE FOR INVESTIGATION. RESOLUTION: CALLER WAS ABLE TO SUCCESSFULLY FILL A CARTRIDGE. NO FURTHER ACTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123990 NEEDLE 26X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305111 UNKNOWN 30382903051114

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other