BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE EXTENSION SET

    MDR report key: 2388610 · Received December 14, 2011

    Report

    Report Number
    9616066-2011-00835
    Event Type
    Malfunction
    Date Received
    December 14, 2011
    Report Date
    December 6, 2011
    Manufacturer
    CARE FUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INDICATED THEY WERE DISPOSING OF THE SET. UNABLE TO DETERMINE THE CAUSE OF THE REPORTED HOLE IN TUBING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THEY CLOSED THE UPPER CLAMP IT CAUSED A HOLE IN THE TUBING. NOT SURE HOW MANY TIMES THEY MIGHT HAVE OPENED AND CLOSED IT BEFORE HOLE HAPPED. CUSTOMER STATED THAT NO FURTHER PT/EVENT INFORMATION IS AVAILABLE. THERE WAS NO REPORT OF PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSITE EXTENSION SET FPA CARE FUSION CORP 30262E UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK