BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 1661964 · Received April 12, 2010

    Report

    Report Number
    1722139-2010-00040
    Event Type
    Other
    Date Received
    April 12, 2010
    Date of Event
    September 30, 2008
    Report Date
    April 7, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) THREE INDIVIDUAL INCIDENTS WERE MENTIONED WHICH REPORTEDLY OCCURRED OVER A 14 MONTH TIME FRAME. INCIDENT #1 WAS REPORTED TO MOOG BY THE CUSTOMER AND MDR'S 2031921-2008-00056 AND 1722139-2010-00024 (FOLLOW UP) WAS SUBMITTED. INCIDENT #2 WAS REPORTED TO MOOG BY THE CUSTOMER AND MDR'S 2031921-2008-00055 AND 1722139-2010-00039 (FOLLOW UP WAS SUBMITTED). INCIDENT #3 WAS REPORTED TO MOOG (B)(4) AND AN MDR 1722139-2010-00020 WAS SUBMITTED.

    Description of Event or Problem · 1

    EVENT AS REPORTED: THIS COMPLAINT WAS REC'D (B)(4) STATING THAT "THE LEAK OCCURRED AFTER THE THICKER TUBING THREADS THROUGH THE PUMP WHERE IT JOINT S WITH THE THINNER TUBING THAT DELIVERS THE TPN". NO PT 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 340-4128

    Patients

    Seq Age Sex Outcome Treatment
    1