Espocan® 333192Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04046964179266), received between Feb 10, 2017 and Dec 3, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: A NURSE WAS HELPING A PATIENT OUT OF BED AND FOUND THAT THE CATHETER HAD BROKEN, WITH SOME OF THE CATHETER STILL IN THE PATIENT'S BACK. THE NURSE REMOVED THE REMAINDER OF THE CATHETER, ENSURING THE TIP WAS INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704376 ↗
• MalfunctionMay 1, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: DESCRIPTION SUMMARY: WANTED TO MAKE EVERYONE AWARE WE HAD AN EPIDURAL CATH THAT BROKE OFF INTO A PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19220350 ↗
• MalfunctionApr 29, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION - "AN EPIDURAL CATH THAT BROKE OFF INTO A PATIENT." DESCRIPTION OF THE PATIENT EVENT - "EPIDURAL CATH BROKE OFF INTO PATIENT." NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19202175 ↗
• MalfunctionMar 19, 2024Break; Break

  AS REPORTED BY THE USER FACILITY: WRITING TO REPORT A BROKEN CATHETER FROM THIS PRODUCT: PRODUCT: ESPOCAN COMBINED SPINAL AND EPIDURAL ANESTHESIA KIT LOT: 0061917773. PRODUCT#: ES1827K. A 2 CM PORTION REPORTED TO BE RETAINED PER MDA.

  Patient problems: Foreign Body In Patient

  MAUDE report 18928520 ↗
• MalfunctionApr 11, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: CRNA INSERTED AN EPIDURAL CATHETER FOR PATIENT'S VAGINAL DELIVERY. WHEN REMOVING THE CATHETER, NURSE OBSERVED THAT THE TIP OF THE CATHETER WAS MISSING, AND THE END WAS IRREGULAR. NURSE THAT REMOVED CATHETER INDICATED THERE WAS NO RESISTANCE DURING REMOVAL. THE B. BRAUN CATHETER WAS COMPARED TO OTHERS, AND IT WAS DETERMINED TO BE 2.25 INCHES SHORTER THAN THE OTHER UNUSED CATHETERS. THE PATIENT WAS X-RAYED, AND NOTHING WAS FOUND. PATIENT WAS NOT SYMPTOMATIC. PATIENT WAS DISCHARGED THE NEXT DAY. THE OB PROVIDER REACHED OUT TO A NEUROSURGEON. THE NEUROSURGEON RECOMMENDED ADDITIONAL RADIOLOGICAL VIEWS (4 CERVICAL VIEWS; SACRAL, L-S, AP LATERAL VIEW) OF THE PATIENT. THE PATIENT HAD ADDITIONAL XRAYS OF HER THORACIC SPINE, SKULL, CERVICAL SPINE AND SACRUM/COCCYX AREA AND NO FOREIGN BODY WAS FOUND.

  Patient problems: Foreign Body In Patient

  MAUDE report 16711972 ↗
• MalfunctionNov 5, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: PATIENT ARRIVED TO LABOR AND DELIVER FOR C-SECTION. EPIDURAL CATHETER TIP BROKE OFF DURING PLACEMENT. THE PATIENT RECEIVED AN EPIDURAL CATHETER; CATHETER NOT BELIEVED TO BE IN A FUNCTIONING POSITION. UPON REMOVAL, THE CATHETER BROKE AND 7.5 CM WAS RETAINED. A NEUROSURGICAL CONSULT DID DETERMINE THAT NO SURGICAL INTERVENTION WAS REQUIRED AT THIS TIME. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8037444 ↗
• MalfunctionFeb 10, 2017Break; Break

  AS REPORTED BY USER FACILITY: CLINICIAN INSERTED EPIDURAL CATHETER AND THOUGHT IT WASN'T IN THE CORRECT LOCATION. CLINICIAN REMOVED THE EPIDURAL CATHETER AND NOTICED THE TIP WAS MISSING FROM THE EPIDURAL CATHETER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6321765 ↗