BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN/PSI KIT

    MDR report key: 2803167 · Received October 19, 2012

    Report

    Report Number
    1036844-2012-00300
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DYB
    PMA / PMN Number
    K002507
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE OPERATING ROOM AFTER PLACING THE CATHETER INTO THE PT'S INTERNAL JUGULAR VEIN, A BLOOD LEAK WAS FOUND AT THE CONNECTION BETWEEN THE SHEATH VALVE AND THE CATH-GARD. IT WAS NOTED THAT AFTER THE CATHETER WAS INSERTED, THE USER REMOVED AND REINSERTED THAT CATHETER AGAIN. IT WAS UNK AND NO INFORMATION AVAILABLE AS TO WHY THAT WAS DONE. AFTER THE LEAK HOWEVER, THE CATHETER WAS REMOVED BUT REPLACED AS THE TREATMENT WAS COMPLETE. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN/PSI KIT CRITICAL CARE PSI PRODUCTS DYB ARROW INTERNATIONAL INC RF2046064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN