BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 12536143 · Received September 27, 2021

    Report

    Report Number
    1911916-2021-01023
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    July 22, 2021
    Report Date
    September 10, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED WHEN PREPARING MEDICATION A BD LUER-LOK SYRINGE HAS A SMALL PIECE OF PLASTIC IN THE TIP OF THE SYRINGE. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. BOTH PHOTOS SHOW A SYRINGE WITH A LUER TIP THAT HAS AN EXCESS OF PLASTIC. THE SYRINGE BARREL SHOWS MARKS ON ONE SIDE THAT GO UP TO THE LUER TIP AS WELL. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR DURING THE MOLDING PROCESS IF THE TEMPERATURE DROPPED WHILE THE PART WAS BEING MOLDED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT NUMBER 0062293. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. MOLDING PARAMETERS WERE VERIFIED FINDING THEM ACCEPTABLE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE OF PLASTIC WAS FOUND IN THE BD LUER-LOK¿ TIP SYRINGE TIP WHILE PREPARING MEDICINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN OBJECT INSIDE SYRINGE TIP WHEN PREPARING MEDICATION, IT IS DISCOVERED THAT A BD LUER-LOK SYRINGE HAS A SMALL PIECE OF PLASTIC IN THE TIP OF THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430344 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 0062293 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1