BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 ML BD LUER-LOK TIP SYRINGE

    MDR report key: 12215078 · Received July 22, 2021

    Report

    Report Number
    1911916-2021-00722
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 24, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED AN ANT WAS FOUND IN THE BD 30ML SYRINGE AFTER MIXING AND ASPIRATING SOLUTION FROM A VIAL. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. BOTH PHOTOS SHOW A SYRINGE CONNECTED TO A NEEDLE ASSEMBLY. THE SYRINGE HAS SOLUTION IN IT AND A FOREIGN MATTER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 0062957. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITH NO PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING AND ASPIRATING SOLUTION THE 30 ML BD LUER-LOK¿ TIP SYRINGE WAS FOUND TO HAVE FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN ANT (INSECT) WAS FOUND IN THE BD 30ML SYRINGE AFTER MIXING AND ASPIRATING SOLUTION FROM CLOXACILLIN VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105426 30 ML BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 302832 0062957 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1