BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR SDZ

    MDR report key: 8279785 · Received January 25, 2019

    Report

    Report Number
    3009081593-2019-00101
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    January 18, 2019
    Report Date
    January 24, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    UDI-DI
    00382908607049
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. PMA / 510(K)#: K011369, K122558. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR A CAN'T INJECT PROBLEM DETECTED BY END USER. NEITHER PHOTO NOR SAMPLE 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 MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. IT SHOULD BE NOTED THAT TESTS PERFORMED BY BD (B)(4) DURING PRODUCTION CONTROLS ARE RELATED TO THE ASSEMBLED DEVICE, WITHOUT USING SYRINGE AND PLUNGER ROD. TESTING OF COMBINATION PRODUCT IS OUT OF SCOPE FOR SAFETY DEVICE MANUFACTURING. 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. INVESTIGATION CONCLUSION: UNCONFIRMED, NO ISSUE OBSERVED. ROOT CAUSE DESCRIPTION:" 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 · 1

    IT WAS REPORTED THAT AFTER INJECTION THE SAFETY DEVICE ON A ULTRASAFE X100L PNG CLEAR SDZ FAILED TO ACTIVATE AND RETRACT THE NEEDLE FROM THE INJECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69856 ULTRASAFE X100L PNG CLEAR SDZ PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 7300818 00382908607049

    Patients

    Seq Age Sex Outcome Treatment
    1 Other