BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV PLUS 4" MINI-BORE EXTENSION SET WITH SPLIT SEPTUM

    MDR report key: 5981274 · Received September 27, 2016

    Report

    Report Number
    3009382876-2016-00001
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Product Code
    FPA
    PMA / PMN Number
    K092930
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "THE AFFECTED PRODUCT (AND LOT NUMBER) WAS NOT AVAILABLE FOR INVESTIGATION. HUMMINGBIRD MED DEVICES INC. TESTED UNITS FROM THE HOSPITAL INVENTORY THAT PASSED OUR PULL STRENGTH AND INTERNAL PRESSURE TESTS. AS A RESULT OF OUR INVESTIGATION WE COULD NOT DETERMINE ANY DEVICE FAILURE MECHANISM THAT MAY HAVE CONTRIBUTED TO WHAT WAS EXPERIENCED DURING USE OF OUR PRODUCT. THE DEVICE IS INTENDED ONLY FOR USE WITH THE HUMMI MICRO DRAW DEVICE AND HAS NOT BEEN TESTED FOR PICC LINE APPLICATIONS. THERE APPEARS TO BE NO MANUFACTURING NOR DESIGN DEFECTS BASED ON THE TESTS CONDUCTED."

    Description of Event or Problem · 1

    T-CONNECTOR TUBING BROKE NEAR THE DISTAL (FEMALE END) SITE. THIS TUBING USED TO CONNECT THE IV PUMP TUBING TO THE HUB END OF THE PERIPHERALLY INSERTED PERIPHERAL CATHETER. BLOOD FROM PICC LINE BACKED UP AND CLOTTED OFF THE CATHETER. CLOT COULD NOT BE RESOLVED, AND LINE HAD TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632635 IV PLUS 4" MINI-BORE EXTENSION SET WITH SPLIT SEPTUM SPLIT SEPTUM MICRO-T LUER LOCK T-CONNECTOR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1