BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBD-GU LAPAROSCOPY PACK

    MDR report key: 18896747 · Received March 13, 2024

    Report

    Report Number
    1423395-2024-00345
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    March 6, 2019
    Report Date
    March 12, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OHD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A 10ML SYRINGE COMPONENT WAS NOT MEASURING 10ML. 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. NO SAMPLE WAS RETURNED FOR EVALUATION. THE REPORTED PROBLEM/ISSUE WAS UNABLE TO BE CONFIRMED AND A ROOT CAUSE WAS UNABLE TO BE DETERMINED. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN (B)(4) ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE COMPONENT WAS NOT MEASURING ACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192205 DBD-GU LAPAROSCOPY PACK OHD MEDLINE INDUSTRIES, LP DYNJ60045

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other