inforMED
MalfunctionOGE

DESIGN OPTIONS®

Received May 8, 2025 · Event occurred Apr 19, 2025

Report 21984581 · MDR key 21984581

Device

Generic name

Epidural Anesthesia Kit

Model number

552116

Catalog number

552116

Lot number

0061981630

Product problems

  • Material Split, Cut or Torn
  • Physical Resistance/Sticking

Patient

32 YR · Female

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

LOSS OF RESISTANCE AT APPROX. 6.5CM. UNABLE TO THREAD CATHETER AT 11CM MARK. TRIED TO GENTLY REMOVE CATHETER AND UNABLE TO REMOVE IT. APPEARED "STUCK". ASKED REGISTERED NURSE (RN) TO CALL FOR ASSISTANCE. NO OTHER INTERVENTIONS AT THAT TIME. ANESTHESIA MD CALLED TO BEDSIDE. WHEN CRNA [CERTIFIED REGISTERED NURSE ANESTHETIST] AND MD AT BEDSIDE, CRNA REMOVED TUOHY NEEDLE AND CATHETER APPEARED SHEARED. INNER COIL OF CATHETER DISENGAGED FROM THE CATHETER ITSELF. INNER COIL WAS SEEN OUTSIDE OF THE PATIENT'S BACK. ANESTHESIA MD ATTEMPTED TO REMOVE ENTIRETY OF THE CATHETER, AND THE INNER COIL RIPPED, AND TIP REMAINED IN PATIENTS BACK.