BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 1981187 · Received January 31, 2011

    Report

    Report Number
    1722139-2011-00018
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 31, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES REPORTED IN THE COMPLAINT WERE DISCARDED BY THE PHARMACY. IT WAS ORIGINALLY REPORTED THAT NO PRODUCT WAS GOING TO BE RETURNED; HOWEVER, SIXTY EIGHT UNUSED SAMPLES WERE RETURNED. THESE SAMPLES ARE CURRENTLY BEING INVESTIGATED. UPON COMPLETION A FOLLOW UP WILL BE SUBMITTED WITH THE RESULTS. THE COMPLAINT DATABASE WAS REVIEWED AND THERE HAVE BEEN NO OTHER REPORTS OF LEAKS IN LOT.

    Description of Event or Problem · 1

    COMPLAINT STATES THAT THE BAG LEAKED AFTER BEING FILLED IN THE CLEAN ROOM AND THAT IT HAPPENED FOUR TIMES. THE CUSTOMER SAID THAT THE LOT NUMBER WAS KNOWN FOR ONLY ONE OF THE 4 OCCURRENCES. THE CUSTOMER WAS CALLED TO GATHER MORE DETAIL ON THE COMPLAINT. ONE OF THE 4 MENTIONED OCCURRENCES IN THE ORIGINAL COMPLAINT WAS NOT RELATED TO THE LEAKS SO THERE WERE 3 REPORTED OCCURRENCES. THE 1ST OCCURRENCE WAS NOT REPORTED TO THE CUSTOMER BY THE PHARMACIST. THE 2ND OCCURRENCE WAS MENTIONED TO THE CUSTOMER BUT THE LOT NUMBER WAS NOT RECORDED. THE 3RD OCCURRENCE INVOLVED LOT D012438. IN ALL THREE OCCURRENCES THE PHARMACIST FILLED THE BAGS WITH VIVAGOLBIN. PRIOR TO USE THE PHARMACY TECHNICIAN(S) SQUEEZE THE BAGS TO LOOK FOR LEAKS. THIS IS WHEN THE LEAKS WERE NOTICED. THE CUSTOMER STATED THAT THERE HAS NOT BEEN ANY OTHER OCCURRENCES SINCE THE COMPLAINT. THERE WERE NO INJURIES DUE TO THE LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4111 D012438

    Patients

    Seq Age Sex Outcome Treatment
    1