BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR NVS STEIN

    MDR report key: 11355349 · Received February 19, 2021

    Report

    Report Number
    3009081593-2021-00010
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Date of Event
    October 27, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K011369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: AN ADDITIONAL PMA/510(K)# IS LISTED AS K122558. (B)(4). INVESTIGATION SUMMARY: UNCONFIRMED: NO EVIDENCE PROVIDED. INVESTIGATION CONCLUSION: THE CUSTOMER ISSUED A COMPLAINT FOR A DETACHED DEVICE DETECTED BY END USER. NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS DID NOT PERFORM A BATCH HISTORY RECORD¿S REVIEW (BHR) BASED ON THE FACTS THAT BATCH RECORD DOES NOT EXTEND TO SYRINGE PRODUCTION AND QUALITY RESULT OVERVIEW IN CASE OF SYRINGE PRODUCTION IS NOT SCOPE BD TATABÁNYA PRODUCTION PROCESS. 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 THE ULTRASAFE X100L PNG CLEAR NVS STEIN EXPERIENCED SAFETY DEVICE SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER OPENED THE PACKAGING BOX ON THE SPOT AND FOUND THAT PART OF THE PRE-INJECTION PEN FELL OFF AND WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251710 ULTRASAFE X100L PNG CLEAR NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 8312560

    Patients

    Seq Age Sex Outcome Treatment
    1