BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC

    MDR report key: 3162161 · Received May 31, 2013

    Report

    Report Number
    1820334-2013-00240
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    May 10, 2013
    Manufacturer
    COOK, INC.
    Product Code
    LJS
    PMA / PMN Number
    K072625
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PICC INTRODUCER DID NOT WANT TO BREAK APART AND THEN THE BREAKAWAY PIECE CAME APART FROM BOTH PLASTIC PIECES LEAVING THE BREAKAWAY INSIDE THE PT. THE RN WAS ABLE TO GET IT OUT AND THE PICC WAS STILL SUCCESSFULLY PLACED. THE NURSE INDICATED SHE PUT A HEMOSTAT ON EACH SIDE AND THEN USED THE THINNEST SCISSORS TO GET IT STARTED. AND THEN MADE SURE A HOLE WAS MADE IN THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240569 TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLYINSERTED CENTRAL VENOUS CATHETER LJS COOK, INC. NA 3662959

    Patients

    Seq Age Sex Outcome Treatment
    1 Other