BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE

    MDR report key: 15442755 · Received September 16, 2022

    Report

    Report Number
    1911916-2022-00500
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 23, 2022
    Report Date
    August 25, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6), USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 301671 AND LOT NUMBER 1082740. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BAG OF BD¿ NEEDLES HAD NO LABEL ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I AM INSPECTING THE (B)(4) SHARP CANNULA 27GA X ¾¿ AND BD BATCH #1082740 IS MISSING A LABEL ON ONE OUT OF THE TWO BAGS IN THE CARTON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123731 BD¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 1082740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown