BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH

    MDR report key: 7330 · Received January 25, 1994

    Report

    Report Number
    7330
    Event Type
    Injury
    Date Received
    January 25, 1994
    Date of Event
    August 13, 1993
    Report Date
    August 25, 1993
    Manufacturer
    PHARMACIA DELTEC, INC.
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 6/11/92, PORT WAS INSERTED. ON 1/4/93, FOLLOW-UP CHEST X-RAY REVEALED PROPER PLACEMENT OF PORT. ON 7/30/93, CHEST X-RAY REVEALED COMPLETE SEPARATION OF THE PROXIMAL PORTION OF THE PORT. ON 8/13/93, PT SENT TO OR FOR REMOVAL OF PORT. CATHETER REMOVED IN PIECES. CHEST X-RAY REVEALED RETAINED FRAGMENT. ON 8/17/93, PERCUTANEOUS REMOVAL OF PORT FRAGMENT FROM THE RIGHT VENTRICLE AND RIGHT ATRIUM UNDER FLUOROSCOPY, WITHOUT COMPLICATION. SPECIMEN KEPT FOR EVAL. SPECIMEN: SEGMENT OF SYNTHETIC TUBE MEASURING 17.6 CM IN LENGTH AND 2.5 CM OVERALL DIMENSION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH Implant UNKNOWN LJT PHARMACIA DELTEC, INC. 21-4000 18846A

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention