BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 30ML LUER-LOK¿ SYRINGE

    MDR report key: 16375987 · Received February 14, 2023

    Report

    Report Number
    1911916-2023-00072
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 24, 2023
    Report Date
    January 27, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 302832 AND LOT NUMBER 2111724. 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 30ML LUER-LOK¿ SYRINGE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DETAILS OF COMPLAINT (REPORTED ISSUE): DEFECTIVE/LEAKING. THE LEAK WAS BETWEEN THE PLUNGER SEAL AND BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166512 BD 30ML LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 2111724 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown