BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    MDR report key: 16287782 · Received February 2, 2023

    Report

    Report Number
    1911916-2023-00049
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 12, 2023
    Report Date
    January 18, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 2243230. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD REPORTS THAT THE DRUGS ARE LEAKING THROUGH THE STOPPER AND AROUND THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347824 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2243230 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown