BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN

    MDR report key: 15921009 · Received December 5, 2022

    Report

    Report Number
    1213809-2022-01162
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    November 9, 2022
    Report Date
    December 22, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903095815
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    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 309581 AND LOT NUMBER 2181981. 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN. HAVE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATES THAT THESE ITEMS HAVE A DEFECT AND HAVE BROKEN OFF IN THE ARMS OF PATIENTS SPILLING APPROXIMATELY $200 WORTH OF VACCINE ON THE GROUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN. HAVE BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATES THAT THESE ITEMS HAVE A DEFECT AND HAVE BROKEN OFF IN THE ARMS OF PATIENTS SPILLING APPROXIMATELY $200 WORTH OF VACCINE ON THE GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536435 BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 25 G X 1 IN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2181981 50382903095815

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown