BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 11276943 · Received February 3, 2021

    Report

    Report Number
    1911916-2021-00091
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 7, 2021
    Report Date
    January 27, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 163099. 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, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. IT CAME IN AN OPENED PACKAGING BLISTER AND A VISUAL INSPECTION WAS PERFORMED. THE BARREL IS CLEAN AND THE PLUNGER ROD HAS FOREIGN MATTER AT THE BOTTOM PART, WHICH IS GREASE FROM THE MOLDING PROCESS. NO OTHER DEFECT OR IMPERFECTION WAS OBSERVED. THE CAUSE FOR THIS DEFECT COULD HAVE RESULTED DURING THE MOLDING PROCESS, WHERE THE MOLDING PRESS COULD HAVE NOT BEEN CLEANED PROPERLY, WHICH WOULD LEAVE A RESIDUE OF LUBRICANT GREASE THAT WAS FOUND ON THE SAMPLE RECEIVED. 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 RED FOREIGN MATTER WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER CALLED TODAY TO REPORT A SYRINGE THAT WAS FOUND THURSDAY THAT CONTAINED FOREIGN MATTER. SHE SAID IT IS RED, SIMILAR TO BLOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169254 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 0163099 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1