BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 10759580 · Received October 29, 2020

    Report

    Report Number
    1911916-2020-00994
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 6, 2020
    Report Date
    October 16, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0062259. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS INCIDENT, 1 PICTURE AND 1 PHYSICAL SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PHYSICAL SAMPLE, A VISUAL INSPECTION WAS PERFORMED. THE BARREL HAS A SCRATCH 3/16¿ LONG AND THE SCRATCH DOES NOT BREAKTHROUGH AND IS NOT AFFECTING FUNCTION. NO OTHER IMPERFECTION WAS OBSERVED. THE PICTURE RECEIVED SHOWS THE PHYSICAL SAMPLE RECEIVED. THE CAUSE FOR THIS DEFECT COULD HAVE RESULTED DURING THE SYRINGE ASSEMBLY PROCESS WHERE A SCRATCH WAS INDUCED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD 60ML SYRINGE LUER-LOK¿ TIP EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A SCRATCH ON THE SYRINGE BARREL. THERE IS A SCRATCH ON THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224726 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0062259 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1