BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X50 PNG CLEAR PFE PUURS

    MDR report key: 10685366 · Received October 15, 2020

    Report

    Report Number
    3009081593-2020-00114
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    June 25, 2019
    Report Date
    September 25, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K011369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8227745; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2018-08-15. MEDICAL DEVICE LOT #: 8236878; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2018-08-24. MEDICAL DEVICE LOT #: 8230960; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2018-08-18. PMA/510(K)#: AN ADDITIONAL PMA/510(K) IS LISTED AS K011369. (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. 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. RATIONALE: COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF ULTRASAFE X50 PNG CLEAR PFE PUURS EXPERIENCED THE USER BEING UNABLE TO ACTIVATE THE SAFETY GUARD AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PATIENT HAD SOME SURGERY, IS USING FRAGMIN FOR 14 DAYS, DID 3 AT HOME, THE FIRST INJECTION WAS FINE, BUT YESTERDAY AND TODAY WHEN DEPRESSED THE SYRINGE THE NEEDLE SHIELD DID NOT RETRACT BACK. DOESN'T KNOW IF SHE GOT HER DOSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152678 ULTRASAFE X50 PNG CLEAR PFE PUURS PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other