BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 6980851 · Received October 26, 2017

    Report

    Report Number
    2523676-2017-00152
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    August 9, 2017
    Report Date
    August 3, 2020
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    OGE
    UDI-DI
    04046964178269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). INITIAL MDR IS BEING SUBMITTED RETROSPECTIVELY DUE TO A FILING ERROR BY B. BRAUN MEDICAL INC. AT THE TIME OF THE REPORTING. THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: DURING PLACEMENT OF EPIDURAL CATHETER FOR FEMALE PATIENT IN LABOR AND DELIVERY, A 7CM PORTION BROKE OFF AND WAS RETAINED IN PATIENT. SECOND EPIDURAL PLACED SUCCESSFULLY. NO FURTHER TREATMENT IS ANTICIPATED; HOWEVER, A NEURO CONSULT WILL BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762044 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MEDICAL INC. 332216 0061562598 04046964178269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention