BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PR PLUM SSL NVS STEIN

    MDR report key: 9728401 · Received February 19, 2020

    Report

    Report Number
    3001741852-2020-00019
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    December 13, 2019
    Report Date
    February 21, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    MEG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: UNCONFIRMED, NO SAMPLE RECEIVED. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. BATCH RECORD REVIEW DID NOT INDICATE OF ANY INCIDENT IN RELATION TO THE PROBLEM STATEMENT. BATCH WAS RELEASED IN ACCORDANCE TO THE ACCEPTABLE CRITERIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ULTRASAFE X100L PR PLUM SSL NVS STEIN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAD A 'FAULTY INJECTOR' AND THAT PRODUCT COULD NOT BE USED. DEFECT COULD NOT BE FURTHER SPECIFIED.

    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 #: 1771817; EXPIRATION DATE: 2023-05-04; MANUFACTURE DATE: 2018-05-10. MEDICAL DEVICE LOT #: 1753135; EXPIRATION DATE: 2023-03-20; MANUFACTURE DATE: 2018-04-03. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ULTRASAFE X100L PR PLUM SSL NVS STEIN WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAD A 'FAULTY INJECTOR' AND THAT PRODUCT COULD NOT BE USED. DEFECT COULD NOT BE FURTHER SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194157 ULTRASAFE X100L PR PLUM SSL NVS STEIN ULTRASAFE MEG BECTON DICKINSON SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other