BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16345540 · Received February 10, 2023

    Report

    Report Number
    1911916-2023-00063
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    January 18, 2023
    Report Date
    February 13, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 309653 AND LOT NUMBER 1112034. 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.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ TIP SYRINGES LEAKED BETWEEN THE PLUNGER SEAL AND BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THREE SEPARATE INCIDENTS OF LEAKING 50 CC SYRINGES. THE LEAK WAS BETWEEN THE PLUNGER SEAL AND BARREL".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ TIP SYRINGES LEAKED BETWEEN THE PLUNGER SEAL AND BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THREE SEPARATE INCIDENTS OF LEAKING 50 CC SYRINGES. THE LEAK WAS BETWEEN THE PLUNGER SEAL AND BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48021 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 1112034 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown