BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-CATH

    MDR report key: 6228 · Received July 27, 1993

    Report

    Report Number
    2183502-1993-00011
    Event Type
    Injury
    Date Received
    July 27, 1993
    Date of Event
    June 14, 1993
    Report Date
    June 16, 1993
    Manufacturer
    LUTHER MEDICAL PRODUCTS
    Product Code
    DXG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    UNIT INSERTED VIA SAPHENOUS VEIN IB=N SIX DAY OLD, 8 WEEK PREMATURE FRMALE INFANT ON 6/8/93 AT APPROX. 400 P.M. ON 6/12/93 UNIT BECAME OCCLUDED. UROKINASE INFUSED THROUGH LINE TO RESTORE PATENCY WHICH APPEARED TO BE SUCCESSFUL INITIALLY. ON 6/13/93, HOWEVER, MORE DIFFICULTY WAS NOTED, AND LINE WAS CAPPED AT THAT TIME WITH HEPARIN LOCK. ON 6/14/93 WHEN CHANGING DRESING, IT WAS NOTED THAT CATHETER HAD BROKEN WITH ONLY 5.5 CM PROXIMAL SEGMENT RECOVERED. ECHOCARDIOGRAM REVEALED DISTAL SEGMENT EMBOLIZED TO SUPERIOR VENA CAVA/RIGHT ATRIAL AREADEVICE 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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: OTHER, NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention