BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL MINIPACK SYSTEM 1 WITH LOCKIT PLUS FIXATION DEVICE

    MDR report key: 8558636 · Received April 26, 2019

    Report

    Report Number
    3012307300-2019-02265
    Event Type
    Injury
    Date Received
    April 26, 2019
    Date of Event
    March 16, 2019
    Report Date
    September 13, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    OGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE UNUSED UNOPENED UNIT PACK OF 100/391/128CZ EPIDURAL MINIPACK SYSTEM 1 WITH CLAMP LOT 3760233 WAS RECEIVED FOR INVESTIGATION. UNDER VISUAL INSPECTION WE FOUND THAT ALL COMPONENTS ARE PRESENT AND NOT DAMAGED. WITHOUT USED SAMPLE WE ARE UNABLE TO DETERMINE TRUE ROOT CAUSE OF THIS INCIDENT. THE CUSTOMER REPORTED CONDITION WAS NOT CONFIRMED. NO FAULT FOUND ON THE REURNED SAMPLE.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL EPIDURAL MINIPACK SYSTEM 1 WITH LOCKIT PLUS FIXATION DEVICE WAS USED DURING EPIDURAL ON A (B)(6) YEAR OLD FEMALE WITH RUPTURED MEMBRANES AND SUSPECTED INTRAUTERINE INFECTION. THE EPIDURAL WAS REPORTED TO BE DIFFICULT DUE TO ABNORMAL DURA AND SPACE IN THE MATTER WITH STRICTURES WAS SUSPECTED BY CLINICIAN. SUBSEQUENTLY, PATIENT SUFFERED SPINAL HEADACHE AFTER OCCURRENCE OF THE SPINAL TAP. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347813 EPIDURAL MINIPACK SYSTEM 1 WITH LOCKIT PLUS FIXATION DEVICE EPIDURAL ANESTHESIA KIT PRODUCT CODE: OGE OGE SMITHS MEDICAL ASD, INC. 3760233

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention