BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERIFIX

    MDR report key: 1051292 · Received May 12, 2008

    Report

    Report Number
    2523676-2008-00033
    Event Type
    Other
    Date Received
    May 12, 2008
    Date of Event
    February 29, 2008
    Report Date
    May 8, 2008
    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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED TO THE MFR TO BE EVALUATED. WITHOUT THE SAMPLE A COMPLETE EVAL COULD NOT BE PERFORMED. INCIDENTS OF THIS NATURE CAN GENERALLY BE ATTRIBUTED TO ONE OF TWO CAUSES. FIRST, THE CATHETER MAY HAVE BECOME LODGED BETWEEN TWO RIGID BODY STRUCTURES AND STRETCHED BEYOND ITS INTENDED DESIGN CAPABILITIES. SECONDLY, THE CATHETER MAY HAVE BEEN WITHDRAWN OR PARTIALLY WITHDRAWN THROUGH THE NEEDLE SHEARING THE CATHETER TIP. IT SHOULD BE NOTED THAT THE LABELING ON THE TRAY STATES, "DO NOT WITHDRAW CATHETER THROUGH THE NEEDLE BECAUSE OF POSSIBLE DANGER OF SHEARING." THE NATURE OF THE FRACTURE COULD NOT BE DETERMINED FROM THE EVENT DESCRIPTION AND ADDITIONAL INFO PROVIDED. WITHOUT THE SAMPLE FOR EVAL, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE MFR B. BRAUN FOR FURTHER EVAL.

    Description of Event or Problem · 1

    EPIDURAL PLACED PER ANESTHESIOLOGIST WITH RN AT BEDSIDE ASSISTING. FIRST CATHETER PLACED WITH BLOOD RETURN AND CATHETER PULLED PER ANESTHESIOLOGIST. CATHETER REMOVED WITH RESISTANCE, BUT DID COME OUT. WHEN CATHETER WAS REMOVED, NO BLUE TIP WAS NOTICED. RN WAS TOLD TO GET SECOND TRAY. UPON COMPARISON OF FIRST AND SECOND CATHETER WAS MISSING ALONG WITH BLUE TIP. SECOND CATHETER WAS PLACED ABOVE FIRST SITE. EPIDURAL WORKED FINE AND PATIENT RECEIVED PAIN CONTROL. THE SCAN WAS NEGATIVE EVEN THOUGH THERE IS A RADIOPAQUE STRIP IN TUBING. DID THIS EVENT INVOLVE ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? LABOR AND DELIVER. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE REMAINING CATHETER SECTION IS BEING RETAINED BY THE RISK MGMT DEPT AND WILL NOT BE RELEASED FOR EVAL. THE PT HAS SUFFERED NO ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THIS INCIDENT. THE FRAGMENTED TIP OF THE CATHETER REMAINS IN THE PT. NO OTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX CUSTOM EPIDURAL ANESTHESIA TRAY CAZ B. BRAUN MEDICAL INC. NA 60970285

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other