BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 8466429 · Received March 29, 2019

    Report

    Report Number
    1911916-2019-00328
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    March 11, 2019
    Report Date
    April 8, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. CORRECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 5ML SALINE FILL CHINA SP IT WAS FOUND THAT THE CAP WAS LOOSE, SOLVED THE ISSUE BY REPLACING A NEW FLUSH.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #8082847 DURING THE PRODUCTION RUN. THIS IS THE FIRST COMPLAINT FOR THE LOT# 8082847 FOR THE SAME DEFECT OR SYMPTOM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE SYRINGE 5ML SALINE FILL CHINA SP IT WAS FOUND THAT THE CAP WAS LOOSE, SOLVED THE ISSUE BY REPLACING A NEW FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260443 SYRINGE 5ML SALINE FILL CHINA SP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8082847

    Patients

    Seq Age Sex Outcome Treatment
    1 Other