BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTIPLEX CONTINUOUS NERVE BLOCK TRAYS

    MDR report key: 3364711 · Received September 19, 2013

    Report

    Report Number
    2523676-2013-00281
    Event Type
    Injury
    Date Received
    September 19, 2013
    Report Date
    August 21, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K813186
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE EVENT DESCRIPTION DID INDICATE THAT THE CATHETER WAS DIFFICULT TO COME OUT. WHILE NO SPECIFIC CONCLUSION CAN BE DRAWN, INCIDENTS OF THIS NATURE CAN OCCUR WHEN A CATHETER BECOMES LODGED BETWEEN RIGID BODY STRUCTURES AND IS STRETCHED BEYOND ITS DESIGN CAPABILITIES. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR CATHETER MATERIAL NUMBER. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER. REVIEW OF THE NONCONFORMING LOT REPORT DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE NOTED DURING IN-PROCESS OR FINAL PRODUCT INSPECTION. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER OF THE CATHETER. IF A PHYSICAL SAMPLE IS RECEIVED OR IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE CATHETER WAS DIFFICULT TO COME OUT, AND WHEN PULLED OUT, THE BLUE TIP REMAINED IN PATIENT, APPROXIMATELY 1/2 CM. THIS WAS A FEMORAL NERVE BLOCK PROCEDURE. DURING A FOLLOW-UP CALL TO THE FACILITY, THE REPORTER STATED A CAT SCAN OF THE AREA INVOLVED DID NOT VISUALIZE THE TIP OF THE CATHETER. THE CATHETER TIP REMAINS IN THE PATIENT. THE PATIENT WAS DISCHARGED WITH NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473043 CONTIPLEX CONTINUOUS NERVE BLOCK TRAYS CNB200TK CONTIPLEX CONT NERVE BLOCK CAZ B. BRAUN MEDICAL, INC. CNB200TK 0061300884

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other