BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCATH RADIOPAQUE CATHETER

    MDR report key: 295 · Received March 2, 1992

    Report

    Report Number
    295
    Event Type
    Injury
    Date Received
    March 2, 1992
    Date of Event
    February 13, 1992
    Manufacturer
    DESERET MEDICAL, INC. PARKE DAVIS & CO.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN ATTEMPTED TO INSERT AN INTERCATH RADIOPAQUE CATHETER INTO A PATIENT'S BRACHEAL VEIN. THE CATHETER BROKE AND A PORTION OF IT REMAINED IN THE VEIN. ANOTHER PHYSICIAN PERFORMED A CUTDOWN, EXPLORED THE VEIN AND RETREIVED THE CATHETER. THE PATIENT'S CONDITION WAS STABLE AS OF 2/18/92DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERCATH RADIOPAQUE CATHETER Implant INTERCATH WITH WIRE STYLET DQX DESERET MEDICAL, INC. PARKE DAVIS & CO. UNKNOWN M2DH660

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention