BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE SPINAL TRAY

    MDR report key: 23757264 · Received December 8, 2025

    Report

    Report Number
    MW5180160
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    December 2, 2025
    Report Date
    December 3, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT IS A G4P3 NOW HERE FOR A REPEAT SCHEDULED C/S. PT UNFORTUNATELY EXPERIENCED THE WEARING OFF OF HER ANESTHETIC MEDICATION AND EXPERIENCED A HIGH LEVEL OF PAIN. SPINAL PLACEMENT PROCEDURE WAS DONE CORRECTLY BY PROVIDER. PT WAS BROUGHT INTO THE OR FOR A SCHEDULE REPEAT C SECTION. SPINAL PROCEDURE WAS PERFORMED BY ANESTHESIA WITH NO APPARENT COMPLICATION. PT WAS LAID DOWN ON OPERATING TABLE. OB SURGEON COMPLETED TEST TO DETERMINE IF SPINAL WAS WORKING AND PT REPORTED SHE COULD NOT FEEL PAIN WHEN HE PINCHED HER AND PROCEDURE WAS STARTED AT 0747. ABOUT 5 MINUTES AFTER PROCEDURE STARTED PATIENT STARTED TO COMPLAIN THAT SHE COULD FEEL SHARP PAIN AND WAS ABLE TO MOVE HER FEET. AFTER BABY BIRTH AT 0754 PT WAS COMPLAINING OF EXTREME PAIN AND WAS LIFTING HER LEGS OFF THE OPERATING TABLE. ANESTHESIA PROVIDER INTERVENED BY GIVING PT ADDITIONAL SEDATIVE MEDICATIONS TO KEEP HER COMFORTABLE UNTIL THE PROCEDURE WAS COMPLETED. PROVIDER ATTEMPTED MULTIPLE TIMES TO GET THE PATIENT NUMB AS THE SURGERY WAS PROGRESSING. ANESTHESIA AND OB SURGEON HAS BROUGHT TO MY ATTENTION THAT THIS IS THE SIXTH SPINAL PROCEDURE IN THE LAST TWO MONTHS THAT HAS BEEN DONE WHERE THE PATIENT HAS FELT THEIR SURGERY. ONLY ONE OF THOSE CASES WAS REPORTED (THE PACKAGING WAS NOT SAVED FROM THAT PROCEDURE). ALL MEDLINE SPINAL KITS HAVE BEEN PULLED IMMEDIATELY. ALL ANESTHESIA PROVIDERS ARE AWARE TO PULL ALL MEDICATION NEEDED FROM THE PYXIS AND TO USE A DIFFERENT KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990381 MEDLINE SPINAL TRAY SPINAL EPIDURAL ANESTHESIA KIT OFT MEDLINE INDUSTRIES, LP - SPT (10)25ABV762

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention| O MEDLINE SPINAL TRAY (0.75% BUPIVACAINE IN DEXTROSE 8.25% 2ML).