NERVE BLOCK TRAY

Additional Manufacturer Narrative

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.

Description of Event or Problem

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".

Additional Manufacturer Narrative

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.