BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTIPLEX

    MDR report key: 1730950 · Received June 17, 2010

    Report

    Report Number
    2523676-2010-00043
    Event Type
    Injury
    Date Received
    June 17, 2010
    Date of Event
    April 17, 2010
    Report Date
    June 1, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    BXN
    PMA / PMN Number
    K860126
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL CATHETER WAS NOT RETURNED TO THE MFR TO BE EVALUATED AND A LOT NUMBER WAS NOT PROVIDED. HOWEVER, THE FACILITY DID RETURN A PHOTOGRAPH FOR EVALUATION. THE PHOTO DEPICTED THE CATHETER LOOPED AND KNOTTED INTO THE CONFIGURATION OF A NOOSE. THE CUSTOMER STATED THAT THIS INCIDENT WAS DUE TO END USER ERROR AND IT WAS DEFINITELY NOT THE PRODUCT. BASED ON THE CUSTOMER'S STATEMENT, THE EVENT DESCRIPTION, AND THE PHOTOGRAPH EVALUATION, THIS INCIDENT CAN BE ATTRIBUTED TO USER/PRODUCT INTERACTION. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED CATALOG NUMBER. THE PHOTOGRAPH AND ALL AVAILABLE INFO HAS BEEN PROVIDED TO THE ACTUAL MFR FOR EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: RECEIVED CALL FROM NURSE SEEKING SUGGESTION HOW TO REMOVE THE CATHETER FROM PT'S GROIN. THE PT HAD RECEIVED A THERMAL NERVE CATH IN HIS LEFT GROIN, LATERAL TO THIGH. DUE TO SOME SKIN GRAFT OF SOME SORT, THE CATHETER WAS AWKWARDLY PLACED. DENIES PHYSICIAN HAVING ANY RESISTANCE WHEN THREADING CATH, ALTHOUGH NURSE NOTED THIS PHYSICIAN TENDS TO THREAD CATHS DEEP. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE CATHETER WAS LOOPED IN THE PT AROUND TISSUE AND WAS SURGICALLY REMOVED WITHOUT INCIDENT. THE PT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE INCIDENT AND WAS DISCHARGED. THE CUSTOMER STATED THAT THE INCIDENT WAS DUE TO END USER ERROR AND IT WAS DEFINITELY NOT THE PRODUCT. THE SAMPLE WAS DISCARDED AND THE LOT NUMBER REMAINS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTIPLEX TUOHY CONTINUOUS NERVE BLOCK SET BXN B. BRAUN MEDICAL, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention