BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 8.5FR X 20CM

    MDR report key: 2993030 · Received March 1, 2013

    Report

    Report Number
    3006425876-2013-00025
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR CONTROL NO: (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THE CATHETER WAS PLACED IN A MALE PT IN THE OPERATING ROOM VIA HIS RIGHT INTERNAL JUGULAR VEIN. THE CATHETER WAS PLACED ON (B)(6) 2013. ON (B)(6) 2013, IN THE INTENSIVE CARE UNIT, IT WAS NOTED THAT THE INFUSION SOLUTION DROPPED OUT THE BLUE EXTENSION LINE NEAR THE HUB. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED BY A CB-25703. THE TIP OF THE CATHETER WAS OUT FOR MICROBIOLOGICAL INVESTIGATIONS (THIS IS BEING DONE REGULARLY). IN OUTER TO LOCATE THE LEAK, THE BLUE EXTENSION LINE WAS FLUSHED. DURING THIS FLUSHING, THE EXTENSION LINE DETACHED WITHOUT ANY FORCE APPLIED. MEDICATIONS INFUSING WERE: ILEUS OP, NACL, PARENTAL NUTRITION: SMOSKABISEN, INTERMITTENTLY SUPPLIED DRUGS: TERAZELIN, TAZOBACTAM, HEPARIN, KALZIUMCHLORID, DELAFUNDIN 4%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90878 CVC KIT: 3-LUMEN 8.5FR X 20CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK