BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML S/T LATEX FREE CONFIGURE

    MDR report key: 11586099 · Received March 29, 2021

    Report

    Report Number
    1911916-2021-00257
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 24, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096542
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309654 AND LOT NUMBER 9133522. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE CAME IN AN OPENED PACKAGING BLISTER AND IS A 60ML SYRINGE. THE SCALE MARKING IS MISSING AND NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR IF THE PRINTING DRUM PAD LOST PRESSURE INDUCING THE SYMPTOM REPORTED BY THE CUSTOMER. THE EQUIPMENT WAS INSPECTED AND WAS FOUND TO BE WORKING SATISFACTORILY. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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 THE SYRINGE 50ML S/T LATEX FREE CONFIGURE HAD NO SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD 60ML SYRINGE DOES NOT HAVE MEASUREMENT MARKINGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481405 SYRINGE 50ML S/T LATEX FREE CONFIGURE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309654 9133522 30382903096542

    Patients

    Seq Age Sex Outcome Treatment
    1