BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 1661540 · Received April 12, 2010

    Report

    Report Number
    1722139-2010-00041
    Event Type
    Other
    Date Received
    April 12, 2010
    Date of Event
    March 12, 2010
    Report Date
    April 7, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED AND THE COMPLAINT WAS CONFIRMED. THE RETURNED SET LEAKED AS REPORTED. THIS IS THE ONLY COMPLAINT THAT HAS BEEN RECEIVED FOR LEAKING AT THE BAG SEAM FOR THE LISTED LOT NUMBERS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED IN THE LAST TWO YEARS. THESE BAG SETS ARE 100% LEAK TESTED IN PROCESS AND MONITORED THROUGH BURST TESTING. THE MANUFACTURER CONFIRMED THAT THE ESTABLISHED PROCESS WAS FOLLOWED WHEN BUILDING THE REPORTED LOT NUMBERS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    EVENT AS REPORTED: INTEGRATED 150 CC BAG BROKE 3 TIMES LEAKS AT SEAMS AND TUBING. PHARMACY TESTED THE BAG WITH WATER AND FOUND THIS TO BE THE CASE. NO PATIENT INJURY REPORTED. NO PATIENT INJURY OCCURRED AS A RESULT OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FPA MOOG MEDICAL DEVICES GROUP 340-4111 D913107/D922209

    Patients

    Seq Age Sex Outcome Treatment
    1