BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2421753 · Received January 13, 2012

    Report

    Report Number
    1722139-2012-00026
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    January 1, 2011
    Report Date
    December 13, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS INCLUDED IN THIS COMPLAINT: CF 1120906, CF 1120907, CF 1122241, CF 1117413, CF1124302, (B)(4). ONE (1) USED ADMIN SET WITHOUT KNOWING LOT NUMBER IN THIS COMPLAINT WAS RETURNED TO MOOG MEDICAL IN (B)(4) FOR EVALUATION. THE ADMIN SET WITH A NON-VENTED CAP WAS AIR PRESSURIZED AND PUT UNDER WATER AND IT DID NOT LEAK. THEN THE ADMIN SET WAS CONNECTED TO THE ALARIS VALVE WITH THE NON-VENTED CAP AND A LEAK WAS DETECTED WITH LESS THAN 1 PSI. THE LOCATION OF THE LEAK WAS AT THE CONNECTION BETWEEN THE ADMIN SET AND THE ALARIS VALVE MADE BY CAREFUSION. THE COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT "HAD TWELVE PATIENTS REPORTING THE PROBLEM TO THE NURSE. THE COMPLAINT IS AS FOLLOWS: THERE IS LEAKAGE BETWEEN THE CONNECTOR AT THE END OF THE SET AND THE INJECTION PORT TO THE PAT. NO PATENT INJURY OCCURRED. MOST OF THERAPIES WERE ANTI-INFECTIVE TPN OR HYDRATION THERAPY. NO CHEMO. DIFFERENT INJECTION PORTS HAVE BEEN USED. MOST USE MAXPLUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4114 D22209

    Patients

    Seq Age Sex Outcome Treatment
    1