BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGON

    MDR report key: 89041 · Received May 2, 1997

    Report

    Report Number
    89041
    Event Type
    Injury
    Date Received
    May 2, 1997
    Date of Event
    March 28, 1997
    Report Date
    April 2, 1997
    Manufacturer
    MAXXIM MEDICAL
    Product Code
    FLN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PIGTAIL FROM ARTERIAL LINE EXTENSION TUBING CAME APART AT MFR'S CONNECTION. THERE HAD BEEN NO UNUSUAL TENSION ON THIS LINE. NURSE INTERVENED IMMEDIATELY. THERE WAS MINIMAL BLOOD LOSS AND NO HARM TO PATIENT. THE EXACT LOT NUMBER IS NOT KNOWN AS THE TUBING WAS HUNG ON 3/27/97 AND PACKAGING DISCARDED. THE LOT NUMBER CURRENTLY IN USE ON THIS NURSING UNIT IS 96113253.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGON PVC EXTENSION TUBE W/MALE LUER LOCK & FLN MAXXIM MEDICAL 041115-002A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention