DESIGN OPTIONS®
Received Oct 1, 2024 · Event occurred Jul 17, 2024
Report 20343267 · MDR key 20343267
Device
Generic name
Epidural Anesthesia Kit
Manufacturer
B. Braun Medical Inc.Model number
552176Catalog number
552176
Lot number
61920360
Patient
25 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
EPIDURAL WAS PLACED FOR PATIENT IN LABOR. AFTER OBTAINING LEVEL OF RESPONSE (LOR), CATHETER WAS THREADED INTO EPIDURAL SPACE WITHOUT DIFFICULTY. ASPIRATION WAS NEGATIVE FOR BLOOD OR CEREBROSPINAL FLUID (CSF). TEST DOSE WAS THEN ATTEMPTED TO BE ADMINISTERED VIA 20CC SYRINGE, BUT VERY DIFFICULT/IMPOSSIBLE TO FLUSH, MEETING A LOT OF RESISTANCE WHEN TRYING TO PUSH THROUGH THE EPIDURAL CATHETER. ALLIGATOR CLAMP WAS THEN REPLACED AND REATTEMPTED TO GIVE TEST DOSE VIA 20CC SYRINGE, AGAIN UNABLE TO FLUSH DUE TO RESISTANCE. 3CC SYRINGE WAS THEN USED TO ADMINISTER TEST DOSE SUCCESSFULLY BUT STILL WITH SOME RESISTANCE. TEST DOSE WAS NEGATIVE, THEN STARTED THE EPIDURAL BOLUS DOSE VIA PATIENT-CONTROLLED EPIDURAL ANALGESIA (PCEA) PUMP. EPIDURAL PUMP WAS UNABLE TO ADMINISTER THE DOSE, ALARMING DOWNSTREAM OCCLUSION BETWEEN PUMP AND PATIENT. EPIDURAL CATHETER WAS THEN FLUSHED USING 10CC SYRINGE WITH PRESERVATIVE-FREE (PF) SALINE, STILL DIFFICULT TO FLUSH THROUGH WITH A LOT OF RESISTANCE. EPIDURAL CATHETER WAS THEN PULLED BACK 1CM AND REATTEMPTED TO FLUSH WITH 10CC SYRINGE BUT AGAIN UNABLE D/T RESISTANCE. THE EPIDURAL CATHETER THEN HAD TO BE REMOVED ENTIRELY AND REPLACED WITH A NEW CATHETER. ONCE THE FIRST CATHETER WAS REMOVED, ATTEMPTED MANUAL FLUSHING OF THE CATHETER TO VISUALIZE ANY ISSUES WITH STILL LOT OF DIFFICULTY TO FLUSH, AND MINIMAL COMING THROUGH THE END OF THE TIP THAT WOULD BE IN THE EPIDURAL SPACE.