BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 27X1/2 RB

    MDR report key: 10901228 · Received November 25, 2020

    Report

    Report Number
    1911916-2020-01060
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 15, 2020
    Report Date
    November 4, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051090
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305109 AND LOT NUMBER 8250590. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 27X1/2 RB HAD A HOLE AND LEAKED MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305109 , BATCH NO: 8250590. IT WAS REPORTED THAT A HOLE ON THE NEEDLE SIDE SEEPED MEDICATION DURING ADMINISTRATION OF A SUBCUTANEOUS PRODUCT. EVENT DESCRIPTION PER EMAIL STATES: DURING THE ADMINISTRATION OF A SUBCUTANEOUS PRODUCT WITH A BD PRECISION GLIDE 27G1/2 NEEDLE, THE ADMINISTRATOR NOTICED MEDICATION ON HER GLOVES. SHE SAW IT WAS COMING OUT FROM A HOLE ON THE NEEDLE SIDE. THE NEEDLE WAS REMOVED, CHANGED AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372187 NEEDLE 27X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8250590 00382903051090

    Patients

    Seq Age Sex Outcome Treatment
    1