BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CATH

    MDR report key: 41042 · Received September 19, 1996

    Report

    Report Number
    41042
    Event Type
    Malfunction
    Date Received
    September 19, 1996
    Date of Event
    September 9, 1996
    Report Date
    September 19, 1996
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT VISIT MADE TO CHANGE PICC LINE DSG AND DRAW LABS. IT WAS DISCOVERED THAT PICC LINE CATHETER HAD BROKEN AT CONNECTION OF CATHETER AND HUB. CATHETER WAS HELD IN PLACE BY STAT-LOK ANCHORING DEVICE AND TRANSPARENT DSG. PICC LINE WAS REPAIRED BUT CATHETER WAS OCCLUDED. PICC LINE DC'D. PT HAD TO HAVE SURGICAL PROCEDURE FOR PLACEMENT OF ANOTHER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC LINE DQO HDC CORP. 360-50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other