BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 27X1/2 RB

    MDR report key: 13285333 · Received January 18, 2022

    Report

    Report Number
    1911916-2022-00004
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    December 22, 2021
    Report Date
    January 6, 2022
    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
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305109 AND LOT NUMBER 0072080. 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. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. 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. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD NEEDLE 27X1/2 RB, THE DEVICE EXPERIENCED THE NEEDLE HUB DAMAGED, CAUSING LEAKAGE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE HAVE HAD SEVERAL THAT HAVE HAD HOLES ON THE SIDE, AND EXTRACT POURED OUT. I HAVE ASKED OTHER NURSES IF IT HAS HAPPENED TO THEM, AND THEY SAID IT HAS. THIS IS A PROBLEM, BECAUSE THE PATIENT IS NOT GETTING THEIR FULL DOSE, AND IT IS HARD TO TELL HOW MUCH IS NOT GOING IN. I GUESS WE ARE GOING TO HAVE TO INSPECT THE INTEGRITY OF THE NEEDLE BEFORE WE USE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121554 BD NEEDLE 27X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 0072080 00382903051090

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown