BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RMC NEURO (BSDCG)195

    MDR report key: 11729536 · Received April 26, 2021

    Report

    Report Number
    1423537-2021-00626
    Event Type
    Malfunction
    Date Received
    April 26, 2021
    Date of Event
    March 23, 2021
    Report Date
    April 26, 2021
    Manufacturer
    MEX03 MEXICO-JUAREZ PRESOURCE
    Product Code
    OJG
    UDI-DI
    10888439398649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON SUPPLIER INVESTIGATION, A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 191130958SH, REVEALED NO EXCEPTION WAS RECORDED THAT COULD LEAD TO THE REPORTED INCIDENT. ACCORDING TO THE SUPPLIER, WORKERS PERFORM THE PROCESS OPERATION IN STRICT COMPLIANCE WITH THE STANDARD OPERATION PROCEDURE OF GAUZE SWAB PRODUCTION. THE ACTUAL COMPLAINT SAMPLE IS NOT AVAILABLE AT THE TIME OF INVESTIGATION; THEREFORE, THE SUPPLIER WAS UNABLE TO DETERMINE THE ROOT CAUSE. THE SUPPLIER WILL CONTINUE TO MONITOR TRENDS FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SPONGE GAUZE(C-NXR4416A) FROM NEUROLOGICAL TRAY(SNE21BSDCH) WAS UNRAVELING DURING LUMBAR DISC PROCEDURE. THE GAUZE SPONGE WAS USED FOR REMOVAL AND BLOTTING OF BLOOD AND FLUIDS DURING THE PROCEDURE. REPORTEDLY, FRAYING FROM THE GAUZE SPONGE WAS FOUND ON THE PATIENT AND ON SCRUB TECH¿S HANDS. THERE WAS NO INJURY, ADVERSE EFFECT OR COMPLICATIONS. NO PATIENT DEMOGRAPHICS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621866 RMC NEURO (BSDCG)195 NEUROLOGICAL TRAY OJG MEX03 MEXICO-JUAREZ PRESOURCE SNE21BSDCH 484493 10888439398649

    Patients

    Seq Age Sex Outcome Treatment
    1