BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH PERIPHERALLY INSERTED CATHETER

    MDR report key: 4764 · Received May 4, 1993

    Report

    Report Number
    2183502-1993-00003
    Event Type
    Injury
    Date Received
    May 4, 1993
    Date of Event
    March 22, 1993
    Report Date
    March 26, 1993
    Manufacturer
    LUTHER MEDICAL PRODUCTS
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PICC LINE INSERTED INTO BASILIC VEIN OF 35 YEAR OLD MALE ON APPROX 3/17/93 FOR ANTIBIOTIC INFUSION. WHEN CATHETER NO LONGER NEEDED, MEDICAL PERSONNEL ATTEMPTED TO REMOVE IT ON 3/22/93. PULLING, PLUS SUSTAINED TRACTION ON CATHETER RESULTED IN CATHETER SEPARATION ABOUT 1" BEFORE VEIN ENTRY SITE. PT WAS SENT TO EMERGENCY ROOM WHERE CATHETER WAS FINALLY REMOVED WITHOUT SURGERY ACCORDING TO NURSE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PERIPHERALLY INSERTED CATHETER Implant PERIPHERALLY INSERTED CENTRAL CATHETER DXG LUTHER MEDICAL PRODUCTS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention