BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTW, XK, 23CM, ST, SPLIT TIP, STANDARD KIT

    MDR report key: 2844424 · Received November 5, 2012

    Report

    Report Number
    3006260740-2012-00393
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 12, 2012
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K090101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A DETACHED SURECUFF AND HEAT SLEEVE IS CONFIRMED. GROSS AND MICROSCOPIC EXAMINATIONS CONFIRM A COMPLETE SEPARATION OF THE SURECUFF/HEAT SLEEVE FROM THE CATHETER. THE DETACHED HEAT SLEEVE/SURECUFF WAS NOT RETURNED FOR EVALUATION. ACCORDING TO THE NOTES CONTAINED IN THE COMPLAINT INCIDENT REPORT THE COMPLAINANT INDICATES THE HEAT SLEEVE/SURECUFF "DID NOT COME OUT WITH THE CATHETER UPON REMOVAL." NO FURTHER INFORMATION IS AVAILABLE AS TO THE LOCATION OF THE HEAT SLEEVE/SURECUFF AT THIS TIME. AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. A LHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE CATHETER MIGRATED OUT, EXPOSING THE CUFF AND RESULTED IN THE NEED TO REPLACE THE CATHETER. THE CUFF DID NOT COME OUT WITH THE CATHETER UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTW, XK, 23CM, ST, SPLIT TIP, STANDARD KIT MSD C. R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1