BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE PLUS X100L PNG CLEAR

    MDR report key: 10320595 · Received July 24, 2020

    Report

    Report Number
    3009081593-2020-00076
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    April 14, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: COMPLAINT IS BEING CANCELLED BECAUSE IT IS A DUPLICATE OF (B)(4). THE DIFFERENT BATCH NUMBERS IN EACH COMPLAINT ARE FOR INFORMATION ONLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ULTRASAFE PLUS X100L PNG CLEAR HAD A SAFETY DEVICE FAILURE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED 2 INDEPENDENT CUSTOMER COMPLAINTS FROM DIFFERENT SOURCES WITH REPORTED DEFECT: ¿PARTIALLY ACTIVATED¿ FOR FINISHED PRODUCT OF NIVESTYM.

    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 #: 7093120. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2017-04-03. MEDICAL DEVICE LOT #: 8247999. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-09-04. MEDICAL DEVICE LOT #: 9241869. MEDICAL DEVICE EXPIRATION DATE: 2024-07-31. DEVICE MANUFACTURE DATE: 2019-08-29. 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 ULTRASAFE PLUS X100L PNG CLEAR HAD A SAFETY DEVICE FAILURE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED 2 INDEPENDENT CUSTOMER COMPLAINTS FROM DIFFERENT SOURCES WITH REPORTED DEFECT: ¿PARTIALLY ACTIVATED¿ FOR FINISHED PRODUCT OF NIVESTYM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783389 ULTRASAFE PLUS X100L PNG CLEAR PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other