Espocan® 333196 (UDI 04046964179303)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046964179303), received between Feb 17, 2017 and May 18, 2022 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: THE PATIENT GAVE INFORMED CONSENT FOR COMBINED SPINAL EPIDURAL (CSE) ANESTHESIA AND WAS BROUGHT TO AN OPERATING ROOM. THE PATIENT ASSUMED A SITTING POSITION, AND AN ANESTHESIOLOGY RESIDENT, WHO WAS APPROXIMATELY HALFWAY THROUGH THEIR CA1 YEAR (RESIDENT IN FIRST YEAR OF CLINICAL ANESTHESIOLOGY TRAINING), PERFORMED LOCAL INFILTRATION WITH APPROXIMATELY 3 ML OF LIDOCAINE 1% AT THE MIDLINE OF THE L5/S1 INTERSPACE USING A 27-GAUGE NEEDLE THAT WAS 3.2 CM IN LENGTH ATTACHED TO A 3-ML LUER LOCK SYRINGE. THE CSE KIT USED WAS AN EPOSCAN COMBINED SPINAL AND EPIDURAL ANESTHESIA TRAY MANUFACTURED BY B. BRAUN MEDICAL. A CSE TECHNIQUE WAS THEN ATTEMPTED AT THIS INTERSPACE, AND INSERTION OF THE 12.7-CM PENCAN 25-GAUGE SPINAL NEEDLE THROUGH THE TUOHY NEEDLE DID NOT PRODUCE BACKFLOW OF CEREBROSPINAL FLUID. RATHER THAN ADMINISTER ANESTHESIA IN THE EPIDURAL SPACE, THE PLAN WAS TO REATTEMPT A CSE AT A DIFFERENT LUMBAR INTERSPACE. THE ANESTHESIOLOGY RESIDENT PROVIDED LOCAL INFILTRATION AT THE L4/L5 INTERSPACE WITH AN ADDITIONAL 3 ML OF LIDOCAINE 1% WITH THE SAME 27-GAUGE NEEDLE. IN CONDUCTING THIS LOCAL ANESTHETIC INFILTRATION, THE RESIDENT INSERTED THE NEEDLE SUPERIOR

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 14427196 ↗
• InjuryAug 14, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: WIRE FROM FX SPRINGWOUND CATHETER WAS LEFT IN PATIENT'S BACK. DETAILS OF REPORT: PATIENT HAD FIRST EPIDURAL PLACED UNSUCCESSFULLY (NOT A B.BRAUN PRODUCT) TRIED THIS DEVICE FOR 2ND ATTEMPT, ALSO UNSUCCESSFUL. USED A 3RD KIT (NOT A B.BRAUN PRODUCT) TO SUCCESSFULLY PLACE EPIDURAL. WHEN PLACING CATHETER ON SECOND ATTEMPT RESISTANCE WAS MET, "FELT LIKE A BURR". REMOVED NEEDLE AND CATHETER TOGETHER, BUT PART OF CATHETER REMAINED, NOTED METAL IN SKIN. PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO HAVE CT SCAN OF ARE DUE TO PARESTHESIA OF THE SKIN FROM RIB CAGE DOWN MOST PRONOUNCED TO LEGS FRONT AND BACK. CT REVEALED A METAL WIRE FRAGMENT. SURGERY TO REMOVE FRAGMENT REVEALED APPROXIMATELY 10 CM OF CATHETER FROM PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10406461 ↗
• MalfunctionMay 11, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PATIENT DID NOT GET RELIEF FROM THE EPIDURAL AND THE CATHETER NEEDED TO BE REMOVED. DURING THE REMOVAL PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS TORN IN TWO. NO PIECE WAS RETAINED. NO LEAKAGE WAS NOTED DURING THE TREATMENT. NO INJURY REPORTED.

  Patient problems: Pain; Therapeutic Response, Decreased

  MAUDE report 10042608 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 3: CUSTOMER REPORTS, "WE HAVE HAD ABOUT 7 INSTANCES WHERE THE CATHETER CONNECTOR COMES OFF OF THE EPIDURAL." NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075108 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 5: CUSTOMER REPORTS, "WE HAVE HAD ABOUT 7 INSTANCES WHERE THE CATHETER CONNECTOR COMES OFF OF THE EPIDURAL." NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075107 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS, "WE HAVE HAD ABOUT 7 INSTANCES WHERE THE CATHETER CONNECTOR COMES OFF OF THE EPIDURAL." NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075106 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS, "WE HAVE HAD ABOUT 7 INSTANCES WHERE THE CATHETER CONNECTOR COMES OFF OF THE EPIDURAL." NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075103 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 4: CUSTOMER REPORTS, "WE HAVE HAD ABOUT 7 INSTANCES WHERE THE CATHETER CONNECTOR COMES OFF OF THE EPIDURAL." NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075101 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 6: CUSTOMER REPORTS, "WE HAVE HAD ABOUT 7 INSTANCES WHERE THE CATHETER CONNECTOR COMES OFF OF THE EPIDURAL." NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075098 ↗
• MalfunctionSep 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY THE USER FACILITY: EVENT 7: CUSTOMER REPORTS, "WE HAVE HAD ABOUT 7 INSTANCES WHERE THE CATHETER CONNECTOR COMES OFF OF THE EPIDURAL." NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9075097 ↗
• MalfunctionFeb 17, 2017Break; Break

  AS REPORTED BY USER FACILITY: CATHETER SHEARED OFF INTO PATIENT APPROXIMATELY 3MM.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6339449 ↗