BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 8722523 · Received June 21, 2019

    Report

    Report Number
    1911916-2019-00614
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 7, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLE WAS RECEIVED. INVESTIGATION CONCLUSION: THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH 8100542 DURING THIS PRODUCTION RUN. THIS IS THE FIRST COMPLAINT FOR THE LOT# 8100542 FOR THE SAME DEFECT OR SYMPTOM. ROOT CAUSE DESCRIPTION: ROOT CAUSE CAN¿T BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 10ML SALINE FILL (B)(6) SP EXPERIENCED A DAMAGED/CRACKED/DEFORMED SYRINGE BARREL NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USE, THE CUSTOMER FOUND THE SYRINGE BARREL HAS CRACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515439 SYRINGE 10ML SALINE FILL CHINA SP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8100542

    Patients

    Seq Age Sex Outcome Treatment
    1 Other