BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 1625931 · Received March 2, 2010

    Report

    Report Number
    1722139-2010-00020
    Event Type
    Other
    Date Received
    March 2, 2010
    Date of Event
    January 4, 2010
    Report Date
    March 1, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MOOG CANNOT CONFIRM THE BASIS OF THIS COMPLAINT. THIS COMPLAINT WAS NOT REC'D BY MOOG AND INFO ON THE EVENT IS LIMITED IN THE MAUDE EVENT REPORT. MAUDE EVENT REPORT STATES THE PRODUCT IS AVAILABLE FOR EVAL; HOWEVER, THE REPORTER IS UNK AND THE DEVICE IS NOT AVAILABLE FOR MOOG'S EVAL. IF THE DEVICE BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(4) 2010, A MAUDE EVENT REPORT (B)(4) WAS REC'D BY MOOG MEDICAL. DESCRIPTION IN MAUDE EVENT REPORT: (B)(6) SET IV TUBING REF (B)(4) LEAKED DURING PARENTERAL NUTRITION INFUSION. TUBING LEAKED AT THE JUNCTION OF THE CASSETTE TUBING TO THE SMALLER BORE IV TUBING JUST AFTER THE GOLD CONNECTOR, AND OCCURRED AS THE INFUSION COMPLETED THE RAMP UP RATE AND WAS AT CONTINUOUS INFUSION RATE. THE INFUSION TUBING WAS REPLACED WITH THE SAME TUBING FROM A DIFFERENT LOT NUMBER AND INFUSION CONTINUED WITHOUT DIFFICULTY. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FPA MOOG MEDICAL DEVICES GROUP 340-4128 D90711

    Patients

    Seq Age Sex Outcome Treatment
    1