BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SPECTRUM TURBO-JECT PICC SET - MINOCYCLINE/RIFAMPIN IMPREGNATED

    MDR report key: 6812734 · Received August 23, 2017

    Report

    Report Number
    6812734
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 10, 2017
    Manufacturer
    COOK INCORPORATED
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT #1 ¿ 3 FR SINGLE LUMEN SPECTRUM PICC LOT # 7421921. HUB (PORTION WHERE THE NEEDLELESS CONNECTOR ATTACHES) OF CATHETER COMPLETELY SEPARATED FROM THE PICC CATHETER INSERTED FOR SINGLE INDICATION ¿ CONTINUOUS MILRINONE INFUSION EVENT #2 ¿ 3 FR SINGLE LUMEN SPECTRUM PICC LOT # 7143607. "LEAKED FROM HUB AREA" CATHETER INSERTED FOR A SINGLE INDICATION ¿ CONTINUOUS MILRINONE INFUSION EVENT #3 ¿ 3FR SINGLE LUMEN SPECTRUM PICC LOT # 6265569. "LEAKING ¿CRACK IN HUB" CATHETER INSERTED FOR A SINGLE INDICATION ¿ CONTINUOUS TREPROSTINIL INFUSION. EVENT #4 ¿ 3 FR SINGLE LUMEN SPECTRUM PICC LOT # 6813179. STARTED TO LEAK AT HUB AREA AND PRIOR TO REMOVAL, HUB COMPLETELY SEPARATED FROM THE PICC CATHETER INSERTED FOR A SINGLE INDICATION ¿ CONTINUOUS TREPROSTINIL INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593871 COOK SPECTRUM TURBO-JECT PICC SET - MINOCYCLINE/RIFAMPIN IMPREGNATED CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS COOK INCORPORATED 7421921

    Patients

    Seq Age Sex Outcome Treatment
    1 NO.