BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3232293 · Received July 10, 2013

    Report

    Report Number
    1820334-2013-00271
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    June 18, 2013
    Manufacturer
    COOK, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K010034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEEP VEIN THROMBOSIS IS NOT LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED DEEP VEIN THROMBOSIS. PICC LINE WAS REMOVED AND REPLACED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319113 TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK, INC. NA 3662942

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention