BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE PLUS X100L PNG CLEAR

    MDR report key: 11617123 · Received April 5, 2021

    Report

    Report Number
    3009081593-2021-00021
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    March 5, 2021
    Report Date
    March 23, 2021
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR SEPARATION FORCE PROBLEM DETECTED DURING CUSTOMER PROCESS. MEASUREMENT RESULTS WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRASAFE PLUS X100L PNG CLEAR SAFETY DEVICE SEPARATED DURING A SEPARATION FORCE TEST. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON THE (B)(6), AS PART OF OUR PPQ ASSEMBLY PROTOCOL, 200 ASSEMBLED DEVICES WERE TESTED FOR SEPARATION FORCE IN UCB QC LAB. 1 FAILURE WAS OBSERVED OUT OF THE 200 DEVICES TESTED, THE LIMIT BEING NLT44.5N.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514112 ULTRASAFE PLUS X100L PNG CLEAR ANTISTICK SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 0166873

    Patients

    Seq Age Sex Outcome Treatment
    1