BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE PLUS X100L PNG CLEAR

    MDR report key: 8571371 · Received May 1, 2019

    Report

    Report Number
    3009081593-2019-00138
    Event Type
    Malfunction
    Date Received
    May 1, 2019
    Date of Event
    April 15, 2019
    Report Date
    April 22, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7061120. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2017-03-02. MEDICAL DEVICE LOT #: 7066032. MEDICAL DEVICE EXPIRATION DATE: 2021-02-28. DEVICE MANUFACTURE DATE: 2017-03-07. MEDICAL DEVICE LOT #: 7093120. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2017-04-03.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 101 ULTRASAFE PLUS X100L PNG CLEAR EXPERIENCED PRODUCT DAMAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT THEIR NEW MACHINE WAS STOPPED DUE TO OVERLAPPED SPRINGS WHEN THEY ASSEMBLED ULTRASAFE IN THEIR DEVICE. 40 TIMES OUT OF 56524PCS OF LOT 7061120/7066032. 61 TIMES OUT OF 56524 OF LOT 7061120/7066032.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361301 ULTRASAFE PLUS X100L PNG CLEAR SYRINGE FMF BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other