BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX CONTINUOUS EPIDURAL TRAYS

    MDR report key: 3210032 · Received June 27, 2013

    Report

    Report Number
    2523676-2013-00192
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K840179
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH EVALUATION COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE EVENT DESCRIPTION DID INDICATE THAT THE PHYSICIAN MET RESISTANCE WHILE INITIALLY REMOVING THE DEVICE. 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 PRODUCT CATALOG NUMBER IDENTIFIED IN THE REPORTED EVENT. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER OF THE CATHETER. 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 WHILE REMOVING CATHETER, THE CATHETER GOT STUCK. TRIED TAPPING, RESTING, AND THEN ATTEMPTED TO REMOVE. CATHETER DID SHEAR IN PATIENT. NO PATIENT INJURY. DURING A FOLLOW-UP CALL TO THE FACILITY, THE REPORTER STATED THE PATIENT HAD RECOVERED AND TO HIS KNOWLEDGE, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE REPORTER INDICATED THAT A SECTION OF CATHETER, APPROXIMATELY 2.5 - 3.5 CM, WAS LEFT IN THE PATIENT. REPORTER INDICATED RESISTANCE WAS FELT UPON INITIAL ATTEMPT TO REMOVE THE CATHETER. HE THEN STOPPED, TAPPED THE CATHETER, REPOSITIONED THE PATIENT, AND ATTEMPTED TO REMOVE THE CATHETER. THE CATHETER SHEARED, LEAVING THE FRAGMENT IN THE PATIENT. HE FELT THAT THERE WERE THREE POTENTIAL CAUSES: THE CATHETER WAS CAUGHT ON AN ANATOMICAL OBSTRUCTION; THERE WAS A MANUFACTURING FLAW WITHIN THE TIP OF THE CATHETER; OR THE CATHETER COULD HAVE BEEN NICKED BY THE NEEDLE UPON INSERTION WHICH WEAKENED THE CATHETER, AND THEN REMOVAL OF THE CATHETER CAUSED IT TO SHEAR. NO SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293049 PERIFIX CONTINUOUS EPIDURAL TRAYS CE18TK ACCU-BLOC PERIFIX KIT CAZ B. BRAUN MEDICAL, INC. CE18TK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other