Design Options® 555579Recalls & reported problems
B. Braun Medical Inc. · Continuous Epidural Tray · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964316463), received between Jun 24, 2019 and Jul 2, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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
Device problems
- Detachment of Device or Device Component4
Patient problems
- No Known Impact Or Consequence To Patient3
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: EVENT 2: CUSTOMER REPORTS TWO EPIDURAL DISCONNECTIONS. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8753615 ↗MalfunctionJul 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: EVENT 1: CUSTOMER REPORTS TWO EPIDURAL DISCONNECTIONS. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8753613 ↗MalfunctionJun 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS, "PATIENT WITH CANCER HAD A PANCREATECTOMY AND HAD A THORACIC EPIDURAL PLACED FOR POST-OPERATIVE PAIN CONTROL. THE EPIDURAL CATHETER WAS FOUND TO HAVE BECOME DISCONNECTED SPONTANEOUSLY AND THE EPIDURAL CATHETER WAS CONTAMINATED. THE EPIDURAL HAD TO BE REMOVED, AND THE PATIENT DID NOT WANT TO GO THROUGH ANOTHER PLACEMENT, AND THEIR POST-OPERATIVE PAIN CONTROL WAS POOR." NO INJURY REPORTED.
Patient problems: Pain
MAUDE report 8726280 ↗MalfunctionJun 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS, "EPIDURAL CATHETER WAS ACCIDENTALLY DISCONNECTED AND THE CLIP CONNECTOR CAME OFF OF THE CATHETER. THE EPIDURAL WAS CONTAMINATED AND HAD TO BE REMOVED." NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8726275 ↗
Other Epidural anesthesia kit devices
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- Design Options® 552177B. Braun Medical Inc. · Epidural anesthesia kit2 recalls0 reports
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- Perifix® 332079B. Braun Medical Inc. · Epidural anesthesia kit1 recall45 reports
- Perifix® 332097B. Braun Medical Inc. · Epidural anesthesia kit1 recall39 reports
- Perifix® 332220B. Braun Medical Inc. · Epidural anesthesia kit1 recall21 reports
- Perifix® 332078B. Braun Medical Inc. · Epidural anesthesia kit1 recall12 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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