Design Options® 552123Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046955057788), received between Mar 26, 2020 and Jun 17, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionJun 17, 2025Break; Break
AS REPORTED BY THE USER FACILITY: WRITING TO REPORT ANOTHER EVENT OF EPIDURAL CATHETER SHEARING. TODAY ON OB, PLACED A ROUTINE EPIDURAL CATHETER ON 1 ATTEMPT. AFTER THREADING THE CATHETER, SHE ATTEMPTED TO REMOVE THE TUOHY VIA PUSH/PULL AND MET RESISTANCE. SHE THEN REMOVED THE ENTIRE TOUHY FROM THE PATIENT'S BACK TO FIND THE CATHETER SHEARED AS YOU SEE BELOW. LUCKILY, AS SHE CONTINUED TO GENTLY PULL, THE TIP OF THE CATHETER CAME OUT, BUT YOU CAN SEE HOW THIN THE REMNANTS ARE. EASILY COULD HAVE BROKEN OFF AND BEEN LODGED IN THE PATIENT'S BACK AND A MAJOR ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22228900 ↗MalfunctionMar 26, 2020Break; Break
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE CATHETER WAS PLACED WITH NO DIFFICULTY; HOWEVER, UPON REMOVAL, THE BLUE TIP WAS MISSING. THE CATHETER APPEARED TO BE INTACT, BUT THE TIP WAS NOT BLUE. THE END USER COMPARED THE CATHETER SIDE BY SIDE BY ANOTHER CATHETER AND THE LENGTH IS THE SAME. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9884785 ↗
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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