BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20024157 · Received August 22, 2024

    Report

    Report Number
    1213809-2024-00559
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION/CORRECTION. FOLLOWING SUBMISSION OF INITIAL MDR, THE CUSTOMER INFORMATION WAS NOT CORRECTLY REPORTED. SECTION E UPDATED TO REFLECT CORRECT CUSTOMER ADDRESS. EVALUATION: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. BOTH PHOTOS SHOW WHITE PARTICULATES EMBEDDED IN THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE IMPROPERLY MOLDED BARREL IS ASSOCIATED WITH THE MOLDING PROCESS. THIS DEFECT IS OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1082602. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHITE SPOTS WERE IDENTIFIED INSIDE A 1ML LUER LOCK SYRINGE WHILE RECONSTITUTION WAS BEING PERFORMED. IT LOOKED LIKE IT WAS EMBEDDED IN THE SYRINGE. THE SYRINGE HAS BEEN DISCARDED AS IT HAS BEEN USED TO RECONSTITUTE CYTOTOXIC DRUGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397474 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1082602 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown