BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 1677076 · Received May 5, 2010

    Report

    Report Number
    1722139-2010-00058
    Event Type
    Other
    Date Received
    May 5, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 30, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO LOT NUMBER INFORMATION OR PRODUCT CODE INFORMATION WAS AVAILABLE. WITH THE LIMITED INFORMATION NO CONCLUSIONS COULD BE DRAWN. NO CLINICAL INJURY TO PATIENT.

    Description of Event or Problem · 1

    AS REPORTED: TUBING EXPLODED WHILE PRIMING SET WITH CHEMO THERAPY MEDICATION. NO INJURY OCCURRED AS A RESULT OF THIS COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1