BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL ANESTHESIA KIT

    MDR report key: 19392422 · Received May 24, 2024

    Report

    Report Number
    2523676-2024-00542
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    May 6, 2024
    Report Date
    June 5, 2024
    Manufacturer
    B BRAUN MEDICAL INC
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON 31MAY2024 IDENTIFYING THAT THIS COMPLAINT INVOLVES CATALOG #: 4242006-02 BASED ON THIS INFORMATION, THE INITIAL MANUFACTURER REPORT NUMBER (2523676-2024-00542) IS INCORRECT AND A NEW MANUFACTURER REPORT NUMBER FOR THIS INCIDENT IS 9610825-2024-00468.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: THE CATHETER WAS REMOVED FROM THE PATIENT AND THERE APPEARS TO BE A GEL BUILDUP ON THE EXTERNAL PART OF THE CATHETER. THE CLINICIAN PULLED THE CATHETER OUT AND WAS CONCERNED ABOUT THE CATHETER SHEERING OFF INTO THE PATIENT, DUE TO THE BUILDUP OF A CLEAR GEL LIKE SUBSTANCE ON THE EXTERNAL PART OF THE CATHETER.

    Description of Event or Problem · 0

    AS REPORTED BY THE B. BRAUN SALE REP: THE SALES REPRESENTATIVE CALLED TO CHECK ON THE STATUS OF THE RECORD. DURING REVIEW HE CLARIFIED THAT THE DEVICE IN QUESTION WAS THE PINK INTROCAN SAFETY 20 GAUGE - AND THAT THE PRODUCT CODE WAS 4242006-02. CUSTOMER COMPLAINT ADVOCATE UPDATED THE RECORD DURING THE CALL. ADDITIONALLY, HE ASKED FOR ADDITIONAL INFORMATION ABOUT THE PRODUCT AS HE BELIEVES THAT AS THE CATHETER WAS REMOVED FROM THE PATIENT THE CLEAR SUBSTANCE, THEY MAY HAVE NOTED WAS NOT THE CATHETER SHEARING OFF BUT A GEL LIKE SUBSTANCE THAT IS PART OF THE DEVICE TO ALLOW FOR BETTER THREADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2299304 EPIDURAL ANESTHESIA KIT OGE B BRAUN MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown