Espocan® 333194Recalls & reported problems
B. Braun Medical Inc. · ESPOCAN® 18 Ga. x 3-1/2 in. Tuohy, PENCAN® 27 Ga. x 5-1/2 in. Pencil-Point Spinal Needle, PERIFIX® 20 Ga. SoftTip Closed Tip, 5 mL Glass Luer Lock LOR, ESPOCAN Docking System Tray (Kit) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964179280), received between Aug 19, 2019 and Oct 17, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2019Break; Break
AS REPORTED BY THE USER FACILITY: REPORT STATES THAT IT WAS NOTICED THAT THE CATHETER TIP WAS MISSING WHEN REMOVED FROM THE PATIENT. THERE WAS APPROXIMATELY 3-3.5CM RETAINED IN THE PATIENT'S EPIDURAL SPACE. AN XRAY AND CT SCAN WERE PERFORMED. BASED ON THE RESULTS, THE PATIENT MET WITH THE NEUROSURGERY AND DID NOT HAVE THE TIP REMOVED AT THE TIME OF DISCHARGE.
Patient problems: Foreign Body In Patient
MAUDE report 9202620 ↗MalfunctionAug 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS: CATHETER CONNECTOR DISCONNECTED. EXPERIENCING THE CATHETER CONNECTOR OPENING AND THE CATHETER COMING UNDONE WHILE IN USE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8908481 ↗
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- Medline Industries, Inc. DYNJRA1739BMedline Industries, Inc. · Spinal epidural anesthesia kit2 recalls0 reports
- Design Options® 530159B. Braun Medical Inc. · Spinal epidural anesthesia kit2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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