BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLIGATOR CLIP LEAD WIRE

    MDR report key: 2481657 · Received March 9, 2011

    Report

    Report Number
    3008289288-2011-00002
    Event Type
    Other
    Date Received
    March 9, 2011
    Date of Event
    January 6, 2011
    Report Date
    March 9, 2011
    Manufacturer
    CAREFUSION 209 INC.
    Product Code
    GXY
    PMA / PMN Number
    K850108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION DID NOT REPORT THIS EVENT BECAUSE THERE WAS NO DEATH OR SERIOUS INJURY OR THAT THE EQUIPMENT MALFUNCTIONED AND WOULD CAUSE DEATH OR SERIOUS INJURY. CAREFUSION DID NOT RECEIVE THE FAILED PRODUCT, SO WE ANALYZED INVENTORY IN STOCK. THE INVENTORY OF ALLIGATOR CLIPS WAS ANALYZED AND IT WAS FOUND THAT IF THERE IS VARIABILITY IN THE HEIGHT OF THE PUNCHED PIPS, THE HINGE MAY FAIL ON OCCASION. APPROXIMATELY (B)(4) ALLIGATOR CLIPS ARE SOLD ON A YEARLY BASIS AND ONLY (B)(4) OTHER SIMILAR COMPLAINT(S) HAS BEEN RECEIVED IN THE PAST YEAR. ALTHOUGH THE RECURRENCE IS MINIMAL AND THERE IS NO PATIENT OR USER HARM, CAREFUSION ENGINEERING IS CURRENTLY WORKING WITH OUR SUPPLIER TO SEE IF THERE ARE ANY PROCESS IMPROVEMENTS THAT CAN BE MADE TO DECREASE VARIABILITY. CAREFUSION CONSIDERS THIS ISSUE CLOSED; THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE PRODUCT FELL APART UPON USE IN THE STERILE FIELD. THIS IS APPROXIMATELY THE FORTH TIME. NO PATIENT HARM. REF REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLIGATOR CLIP LEAD WIRE ALLIGATOR CLIP LEAD WIRE GXY CAREFUSION 209 INC. NA NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other