BEUDAMED
    FDA Adverse Event Summary report: N

    COOK SPECTRUM TURBO JECT PICC SET

    MDR report key: 2111315 · Received May 24, 2011

    Report

    Report Number
    2111315
    Date Received
    May 24, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 24, 2011
    Manufacturer
    COOK MEDICAL INCORPORATED
    Product Code
    LJS
    Report Source
    User Facility report
    Reporter Location
    IN, US

    Narratives

    Description of Event or Problem · 1

    VENOUS ACCESS NURSE ATTEMPTED TO PLACE PICC LINE IN LEFT UPPER ARM. VENOUS ACCESS NURSE NOTED PICC LINE TO CURL AND UNABLE TO PLACE IN SUPERIOR VENA CAVA. PHYSICIAN NOTIFIED AND RECEIVED ORDER TO REMOVE PICC LINE. VENOUS ACCESS NURSE ATTEMPTED TO PULL BACK ON PICC AND MET RESISTANCE WITH APPROXIMATLY 5CM OF CATHETER STILL WITHIN LEFT BASILIC VEIN. X-RAY OF LEFT HUMERUS ORDERED WHICH REVEALED PICC CATHETER TO BE KNOTTED. SURGEON CONTACTED AND REMOVED CATHETER WITH GENTLE PRESSURE. THE ENTIRE CATHETER REMOVED INTACT. THE RIGHT MIDLINE PLACED WITHOUT DIFFICULTY FOR VENOUS ACCESS.======================MANUFACTURER RESPONSE FOR PICC LINE, COOK SPECTRUM TURBO JECT PICC SET (PER SITE REPORTER)======================WILL SEND A REPLACEMENT SET TO FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK SPECTRUM TURBO JECT PICC SET CATHETER, PICC LJS COOK MEDICAL INCORPORATED * 2700020

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR