Design Options® 552038Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964312380), received between Sep 9, 2019 and Sep 9, 2019 — classified as 1 malfunction.
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
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2019Break; Break
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS, "NURSE ANESTHETIST INSERTED A CATHETER AND UPON REMOVING, THE CATHETER SHEARED OFF AROUND THE 5 CM MARK." THE USER NOTED RESISTANCE AND "WIGGLED" THE CATHETER A LITTLE, AND THE TIP BROKE OFF.
Patient problems: Foreign Body In Patient
MAUDE report 8975933 ↗
Other Epidural anesthesia kit devices
- Design Options® 552116B. Braun Medical Inc. · Epidural anesthesia kit2 recalls7 reports
- Design Options® 552177B. Braun Medical Inc. · Epidural anesthesia kit2 recalls0 reports
- Design Options® 552179B. Braun Medical Inc. · Epidural anesthesia kit2 recalls0 reports
- Design Options® 552126B. 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 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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