BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X50 PNG CLEAR

    MDR report key: 10686930 · Received October 15, 2020

    Report

    Report Number
    3009081593-2020-00117
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    October 29, 2019
    Report Date
    November 30, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    MEG
    PMA / PMN Number
    K011369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR A CAN¿T ACTIVATE SAFETY DEVICE DETECTED BY END USER. NEITHER SAMPLE NOR PHOTO WAS 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 MET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), AND WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ULTRASAFE X100L PNG CLEAR PFE PUURS FAILED IN SAFETY GUARD ACTIVATION AFTER USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "NEEDLE ISSUE (PROBLEMS WITH THE SYRINGE AS THE NEEDLE IS NOT RETRACTING WHEN USED.) WITH FRAGMIN".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ULTRASAFE X100L PNG CLEAR PFE PUURS FAILED IN SAFETY GUARD ACTIVATION AFTER USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER, "NEEDLE ISSUE (PROBLEMS WITH THE SYRINGE AS THE NEEDLE IS NOT RETRACTING WHEN USED.) WITH FRAGMIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152725 ULTRASAFE X50 PNG CLEAR PISTON SYRINGE MEG BD MEDICAL (BD WEST) MEDICAL SURGICAL 8102593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other