BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTAN CHOLANGIOGRAPHY SET

    MDR report key: 3964271 · Received June 19, 2014

    Report

    Report Number
    2242445-2014-00006
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FGE
    PMA / PMN Number
    K905229
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THEATRE. THE USER REPORTED THAT THE BALLOON WAS INSERTED INTO THE PT'S INTRA PERITONEAL AND BURST UPON BEING INFLATED ONCE INSIDE THE PT. AS A RESULT, ANOTHER KIT WAS OPENED AND USED; SEE MDR # 2242445-2014-00007 FOR THE SECOND INCIDENT WITH THE SAME PT. THERE WAS A DELAY REPORTED, HOWEVER, THERE WAS NO HARM TO THE PT. THERE WAS NO COMPLICATION, DEATH OR INJURY REPORTED TO THE PT AS A RESULT OF THESE OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360965 PERCUTAN CHOLANGIOGRAPHY SET CHOANGIOGRAPY CATHETER PRODUCTS FGE ARROW INTL., INC. MF3032845

    Patients

    Seq Age Sex Outcome Treatment
    1