BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DBD-D AND C HYSTEROSCOPY PACK

    MDR report key: 18784799 · Received February 26, 2024

    Report

    Report Number
    1423395-2024-00063
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    November 26, 2019
    Report Date
    February 26, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PLUNGER OF A CONTROL SYRINGE COMPONENT "SNAPPED OFF" WHILE A RESIDENT PHYSICIAN WAS INJECTING LOCAL ANESTHESIA. THE REPORTING FACILITY INDICATED THAT ALL BROKEN PIECES OF THE CONTROL SYRINGE WERE ACCOUNTED FOR. 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 SAMPLE WAS RETURNED FOR EVALUATION. UPON INSPECTION OF THE DEVICE, IT WAS SEEN THAT THERE APPEARED TO BE EXCESSIVE FORCE APPLIED TO THE TOP RING OF THE CONTROL SYRINGE, WHICH WAS SHOWN BY THE STRETCH MARKS AT THE FRACTURE LINES ON THE SYRINGE. IT ALSO APPEARS THAT THE PRESSURE WAS EXERTED WHEN THE PLUNGER WAS SLIGHTLY PULLED OUT, LIKELY LESS THAN 1ML VOLUME, CAUSING THE ROUNDED FRACTURE ON ONE SIDE. THE ROOT CAUSE WAS DETERMINED TO BE USE RELATED WHERE EXCESSIVE FORCE WAS PLACED ON THE COMPONENT IN THE INCORRECT DIRECTION. 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 THE PLUNGER OF A CONTROL SYRINGE COMPONENT "SNAPPED OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120380 DBD-D AND C HYSTEROSCOPY PACK OJF MEDLINE INDUSTRIES, LP DYNJ60857 19FBX077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other