inforMED
MalfunctionOGE

PERIFIX

Received Jul 9, 2024 · Event occurred Jun 6, 2024

Report 19700230 · MDR key 19700230

Device

Generic name

Epidural Anesthesia Kit

Model number

332079

Catalog number

332079

Lot number

0061931106

Patient

NA · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

1ST EPIDURAL ATTEMPT PLACED WITH NO COMPLICATIONS. ALLIGATOR CLIP HOOKED UP AND UNABLE TO INJECT THROUGH. DETACHED FROM PATIENT AND ALL OTHER PARTS WORKING. EPIDURAL CATHETER TRIMMED AND STILL UNABLE TO INJECT. GOT ADDITIONAL CLIP FROM SECOND KIT. SAME DEFECT. CHANGED 20CC SYRINGE TO REMOVE ANY VARIABLE BESIDES CLIP AND STILL UNABLE TO INJECT. EPIDURAL CATHETER REMOVED AND 2ND ONE PLACED WITH DIFFERENT KIT.