BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 23GA 1IN MTW CH

    MDR report key: 10925610 · Received December 1, 2020

    Report

    Report Number
    1911916-2020-01084
    Event Type
    Malfunction
    Date Received
    December 1, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 17, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER: 8025511. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PLASTIC BAG WITH WHAT APPEARS A SYRINGE INSIDE, AND ANOTHER OBJECT RIGHT NEXT TO SYRINGE AND IT IS NOT POSSIBLE TO CLEARLY SEE WHAT IT IS INSIDE OF THE PLASTIC BAG. NO CONCLUSIONS CAN BE OFFERED FROM THE PHOTO, AND NO PHYSICAL SAMPLES WERE RECEIVED, AND A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. ALL THE INSPECTIONS AND TESTING PERFORMED WHILE PRODUCING THIS LOT WERE ACCEPTED. 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 · 1

    IT WAS REPORTED THAT THE NEEDLE NS 23GA 1IN MTW CH EXPERIENCED A NEEDLE THAT WAS LOOSE/PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301657; BATCH NO.: 8025511. COMPONENT MALFUNCTION WHILE IN SERVICE. NEEDLE BECAME DETACHED FROM LUER HOUSING, AND REMAINED INSERTED INTO PATIENT'S ARTERY AFTER REMOVING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392348 NEEDLE NS 23GA 1IN MTW CH HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8025511

    Patients

    Seq Age Sex Outcome Treatment
    1