BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X50 PNG CLEAR PFE PUURS

    MDR report key: 10653245 · Received October 8, 2020

    Report

    Report Number
    3009081593-2020-00104
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    April 22, 2019
    Report Date
    September 23, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7229469, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2017-08-17. MEDICAL DEVICE LOT #: 7234481, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2017-08-22. MEDICAL DEVICE LOT #: 7228256, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2017-08-16. MEDICAL DEVICE LOT #: 7212352, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2017-07-31. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6). PMA/510(K)#: K011369, K122558. (B)(4). INVESTIGATION SUMMARY: UNCONFIRMED, NO ISSUE OBSERVED. INVESTIGATION CONCLUSION: 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. 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. THIS EVENT HAS BEEN LOGGED IN OUR COMPLAINT SYSTEM AND WILL BE SUBJECT TO OUR PERIODIC MANAGEMENT REVIEW AND MAY TRIGGER ADDITIONAL INTERNAL ACTIONS IN CASE OF ABNORMAL TRENDING. RATIONALE: COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ULTRASAFE X50 PNG CLEAR PFE PUURS WAS UNABLE TO ACTIVATE SAFETY GUARD. THIS OCCURRED ON 2 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY HAVE ADDITIONAL REPORTS WHERE ONE NEEDLE FAILED TO RETRACT AND ONE THAT DID NOT CLICK SO THERE WAS SPRAY ON REMOVAL OF NEEDLE FROM INJECTION SITE AND ONLY PARTIAL DOSE ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118464 ULTRASAFE X50 PNG CLEAR PFE PUURS ULTRASAFE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other