BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN ADMINISTRATION SET

    MDR report key: 2860009 · Received October 31, 2012

    Report

    Report Number
    1722139-2012-01098
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    August 22, 2012
    Report Date
    August 22, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ADMINISTRATION SETS WITH LOT # CF1132012 WERE RETURNED TO SLC MOOG FOR INVESTIGATION. THESE ARE SAMPLE SETS, NOT ALLEGEDLY DEFECTIVE SETS. ALL OD DIMENSIONS WERE MEASURED AND WERE WITHIN MOOG SPECS. VISUAL SCOPE REVIEW OF (B)(4) ADMINISTRATION SETS SHOWED NO PARTICULATE ON THE SPIKE. COMPLAINT COULD NOT BE CONFIRMED. SEVERAL ATTEMPTS WERE MADE TO OBTAIN MORE INFO REGARDING TO HOW THE ADMINISTRATION SETS WERE USED, CUSTOMER RESPONDED THAT THERE WAS NO INFO COULD BE PROVIDED.

    Description of Event or Problem · 1

    INFO RECEIVED AS FOLLOWS: DURING THE CONNECTION OF THE ADMINISTRATION KITS WITH THE INFUSION BAGS, PARTICLES OF THE STOPPER ARE PUNCHED-OUT AND GET INTO THE DRUG SOLUTIONS. AFTER INSPECTION OF THE ADMINISTRATION KITS, OUR CUSTOMER HAD DETERMINED THAT THE REASON FOR THE PARTICLES IS THE BLUNT SPIKE OF THE ADMINISTRATION KITS. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN ADMINISTRATION SET FRN MOOG MEDICAL DEVICES GROUP 340-4128 CF1132012

    Patients

    Seq Age Sex Outcome Treatment
    1