BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CATH PICC

    MDR report key: 7195 · Received November 19, 1993

    Report

    Report Number
    7195
    Event Type
    Malfunction
    Date Received
    November 19, 1993
    Date of Event
    November 6, 1993
    Report Date
    November 12, 1993
    Manufacturer
    HDC
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    TIP OF GUIDE WIRE BROKE OFF, LEAVING A STICK IN EMPLOYEE'S RIGHT THUMB. THE PT RECEIVING THE PICC IS KNOWN HIV POSITIVE.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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.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: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC PERIPHERALLY INSERTED CENTRAL CATHETER DQO HDC DUAL LUMEN 4.5. FR 1006

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other