BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBD-GU PACK

    MDR report key: 18768808 · Received February 23, 2024

    Report

    Report Number
    1423395-2024-00042
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    October 29, 2019
    Report Date
    February 22, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A BROKEN SYRINGE COMPONENT WAS FOUND WITHIN THE SURGICAL PACK AND THE SYRINGE COMPONENT COULD NOT BE USED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. A PHOTO WAS PROVIDED AND THE REPORTED PROBLEM/ISSUE WAS CONFIRMED - THE TIP OF THE SYRINGE COMPONENT WAS FOUND TO HAVE BROKEN OFF. NO PHYSICAL SAMPLE WAS RETURNED. IT IS LIKELY THE SYRINGE COMPONENT WAS EITHER DAMAGED PRIOR TO PLACEMENT IN THE SURGICAL PACK OR IT BECAME DAMAGED DUR TO ROUGH HANDLING OF THE SURGICAL PACK. DUE TO THE REPORTED PROBLEM/ISSUE, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BROKEN SYRINGE COMPONENT WAS FOUND WITHIN THE SURGICAL PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125733 DBD-GU PACK LRO MEDLINE INDUSTRIES, LP DYNJ63721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other