BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16500542 · Received March 8, 2023

    Report

    Report Number
    1911916-2023-00124
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 2, 2023
    Report Date
    March 30, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 23-MAR-2023. INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE TIP OF THE PLUNGER ROD WAS BROKEN INSIDE THE STOPPER. POTENTIAL ROOT CAUSE FOR THE BROKEN PLUNGER ROD DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE DEFECTS ARE OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2213779. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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 DURING USE WITH BD LUER-LOK¿ TIP SYRINGE THE PLUNGER BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DURING INJECTION OF METHOTREXATE INTO A 100 ML FREEFLEX NACL BAG, THE PLUNGER OF THE 1 ML SYRINGE BROKE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD LUER-LOK¿ TIP SYRINGE THE PLUNGER BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: DURING INJECTION OF METHOTREXATE INTO A 100 ML FREEFLEX NACL BAG, THE PLUNGER OF THE 1 ML SYRINGE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122212 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 2213779 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown