Design Options® 552076Recalls & reported problems
B. Braun Medical Inc. · Continuous Epidural Tray · Class 2
All models of Design Options (116)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964814013), received between May 17, 2018 and Jan 7, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0126-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Break3
Patient problems
- Foreign Body In Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2025Break; Break
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: "DURING INSERTION OF AN EPIDURAL CATHETER ON A PATIENT, A PORTION OF THE PLASTIC COATING ON THE EPIDURAL CATHETER WIRE REMAINED IN THE PATIENT'S BACK WHILE REMOVING THE CATHETER. THE WIRE CAME OUT OF THE PATIENT'S BACK WITH A SECTION OF APPROXIMATELY 10 CM OF THE COATING MISSING." PULLED OUT CATHETER, NO SURGICAL REMOVAL, DISTAL END OF CATHETER. COULD BE IN THE PATIENT STILL.
Patient problems: Foreign Body In Patient
MAUDE report 21091012 ↗MalfunctionMar 8, 2021Break; Break
AS REPORTED BY THE USER FACILITY: CATHETER TIP BROKE OFF APPROX. AT THE 1 CM MARK DURING THE REMOVAL PROCEDURE. IT WAS STATED THAT THERE WAS MILD RESISTANCE DURING THE REMOVAL PROCEDURE. AN MRI WAS DONE, THE TIP WAS SEEN, BUT THE SURGEON DECIDED TO KEEP THE TIP IN PLACE AND NOT REMOVE. THE PATIENT IS DOING WELL. NO INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 11435121 ↗InjuryMay 17, 2018Break; Break
AS REPORTED BY THE USER FACILITY: DURING PLACEMENT, THE EPIDURAL CATHETER FRACTURED AND THE BLUE TIP WAS NOT INTACT UPON REMOVAL.
Patient problems: Foreign Body In Patient
MAUDE report 7523395 ↗
Other Epidural anesthesia kit devices
- Design Options® 552116B. Braun Medical Inc. · Epidural anesthesia kit2 recalls7 reports
- Design Options® 552126B. Braun Medical Inc. · Epidural anesthesia kit2 recalls0 reports
- Design Options® 552179B. Braun Medical Inc. · Epidural anesthesia kit2 recalls0 reports
- Design Options® 552177B. Braun Medical Inc. · Epidural anesthesia kit2 recalls0 reports
- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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