BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 8FR X 20CM

    MDR report key: 3900306 · Received May 2, 2014

    Report

    Report Number
    1036844-2014-00207
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT OCCURRED IN THE GSICU2 DEPARTMENT DURING INSERTION. THE PHYSICIAN ENLARGED THE CUTANEOUS PUNCTURE SITE BY PERFORMING A SKIN NICK, KEEPING THE CUTTING EDGE OF THE SCALPEL POSITIONED AWAY FROM THE SWG. THE DILATOR WAS THEN USED TO ENLARGE THE SITE AS REQUIRED. THE USER REPORTED THAT THE DILATOR WAS DIFFICULT TO INSERT AND THAT THE TIP "DEFORMED" DURING PLACEMENT. AS A RESULT, THE DILATOR WAS REMOVED AND A NEW KIT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO DELAY, HARM, COMPLICATION, DEATH, OR INJURY REPORTED AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265668 CVC SET: 2-LUMEN 8FR X 20CM ARROWG+ARD CATHETER PRODUCTS. FOZ ARROW INTL., INC. 23F13K0163

    Patients

    Seq Age Sex Outcome Treatment
    1