BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH

    MDR report key: 557981 · Received December 3, 2004

    Report

    Report Number
    2925153-2004-00026
    Event Type
    Other
    Date Received
    December 3, 2004
    Date of Event
    August 14, 2004
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "PT WAS ADMITTED TO THE HOSP IN 2004 WITH ABDOMINAL PAIN, NAUSEA AND VOMITING. PT WENT TO SURGERY FOR SMALL BOWEL OBSTRUCTION AND ADHESION WERE FOUND AND LYSED. 2 DAYS LATER IN 2004 PT HAD V-CATH LINE INSERTED IN RIGHT BASILIC BY IV RN. THE TIP ACCORDING TO RADIOLOGIST WAS AT THE AXILLARY AREA. THE INTERNAL LENGTH WAS 38 CM AND EXTERNAL 13 CM. 10 CM WAS TRIMMED. ARM CIRCUMFERENCES WAS 15 CM ABOVE ANTECUBE THAT WAS 24 CM. THE NEXT DAY 2004 THE PT WAS FOUND WITH THE OUTER PORTION OF THE V-CATH LINE TOTALLY DETACHED AND ON THE FLOORS. THE REMAINING INNER PORTION WAS REMOVED AND MEASURED OUT AS 13 CM AS PER INSERTION RECORDS. THE NURSING STAFF SAVED THIS PORTION OF THE V-CATH. NURSING STAFF DISCARDED THE PORTION OF THE V-CATH FOUND ON THE FLOOR. THE PT HAD NO BLEEDING FROM THE BROKEN V-CATH LINE. PT IS STILL IN THE HOSP." 2004, 15 DAYS LATER RISK MANAGER AT MED CTR, STATED THAT PT DIED 13 DAYS AFTER SURGERY. THE RISK MANAGER CONFIRMED VIA PHONE THAT PT'S DEATH WAS NOT CAUSED BY THE REMOVAL OR BREAKAGE OF THE V-CATH ALSO CONFIRMED THAT DURING AND AFTER THE REMOVAL OF THE CATHETER, PT WAS FINE AND THERE WAS NO ER, MED OR SURGICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH 5 FR DUAL LUMEN PICC DQO HDC CORP. NA 1004

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other