BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG CATHETER

    MDR report key: 3641 · Received July 8, 1992

    Report

    Report Number
    3641
    Event Type
    Injury
    Date Received
    July 8, 1992
    Date of Event
    January 21, 1992
    Report Date
    January 29, 1992
    Manufacturer
    DAVOL PRODUCT
    Product Code
    DQT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    GROSHONG CAHTETER INSERTED SEPTEMBER 1991 FOR USE WITH CHEMOTHERAPY. ON JANUARY 21, 1992 PATIENT ENTERED HOSPITAL TO HAVE GROSHONG REPLACED DUE TO LOSS OF FUNCTION. IN OPERATING ROOM AS DOCTOR REMOVED GROSHONG IT WAS NOTED THE TIP WAS MISSING. THE TIP OF THE CATHETER WAS LOCATED IN THE VENA CAVA AND PARTIALLY INTO THE RIGHT ATRIUM. THE FOLLOWING DAY A RADIOLOGIST WAS ABLE TOSNARE THIS PORTION OF THE GROSHONG THROUGH ANOTHER CATHETER IUNSERTED IN TO THE FEMORAL VEIN. PATIENT WAS DISCHARGED THE FOLLOWING DAY AFTER NEW GROSHONG CATHETER WAS INSERTEDDEVICE 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, TELEMETRY FAILURE, UNANTICIPATED, TUBING. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG CATHETER Implant CV CATHETER W/GROSHONG VALVE DQT DAVOL PRODUCT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention