BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-GUIDEWIRE (CENTRAL LINE)

    MDR report key: 21059 · Received March 7, 1995

    Report

    Report Number
    21059
    Event Type
    Malfunction
    Date Received
    March 7, 1995
    Date of Event
    March 15, 1994
    Report Date
    February 17, 1995
    Manufacturer
    WALRUS CARDIOVASCULAR PRODUCTS
    Product Code
    MKI
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 3/15/1994, A HOUSEOFFICER WAS CHANGING A CENTRAL LINE OVER A GUIDEWIRE. SHE PASSED THE WIRE THROUGH THE OLD CENTRAL LINE AND THEN REMOVED THE LINE. SHE THEN PASSED THE NEW ONE OVER THE WIRE, AND AT THE CLOSE OF THE PROCEDURE, AS SHE WAS ATTEMPTING TO REMOVE THE WIRE, IT WAS NOTED TO BE FRAYED. THERE WAS NO INJURY TO THE PATIENT.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-GUIDEWIRE (CENTRAL LINE) MKI WALRUS CARDIOVASCULAR PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other