BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERVE BLOCK TRAY

    MDR report key: 18767857 · Received February 23, 2024

    Report

    Report Number
    1417592-2024-00102
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 26, 2024
    Report Date
    March 12, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OGI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 WHILE ADVANCING THE PLUNGER TO ADMINISTER MEDICATION FOR A "TRANSFORAMINAL EPIDURAL STEROID INJECTION" USING THE SYRINGE AND A "22G SPINAL NEEDLE PLACED IN THE LUMBAR SPINE OR SACROILIAC AREA", THE PLUNGER "BENT SIDEWAYS AND SNAPPED". ACCORDING TO THE CUSTOMER, AFTER THE REPORTED INCIDENT, THE PHYSICIAN USED ANOTHER SYRINGE IN ORDER TO COMPLETE THE PROCEDURE. THE CUSTOMER REPORTED "NO TREATMENT REQUIRED" RELATED TO THE REPORTED INCIDENT. THE CUSTOMER REPORTED NO SERIOUS INJURY, MEDICAL INTERVENTION/ATTENTION, OR FOLLOW-UP CARE NEEDED RELATED TO THE REPORTED INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATE D4: LOT NUMBER. UPDATE D9: RETURNED TO MANUFACTURER, DATE RETURNED TO MANUFACTURER. UPDATE H3: DEVICE EVALUATED BY MANUFACTURER. UPDATE H6: TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2024 WHILE ADVANCING THE PLUNGER TO ADMINISTER MEDICATION FOR A "TRANSFORAMINAL EPIDURAL STEROID INJECTION" USING THE SYRINGE AND A "22G SPINAL NEEDLE PLACED IN THE LUMBAR SPINE OR SACROILIAC AREA", THE PLUNGER "BENT SIDEWAYS AND SNAPPED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259773 NERVE BLOCK TRAY OGI MEDLINE INDUSTRIES, LP 23IB0899, 23JBU344

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other