Design Options® 551731Recalls & 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 04046964307867), received between Feb 12, 2020 and Feb 9, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break4
Patient problems
- Foreign Body In Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 9, 2021Break; Break
AS REPORTED BY THE USER FACILITY: "UPON REMOVAL OF THE PERIFIX EPIDURAL CATHETER, A PORTION OF THE CATHETER TIP WAS RETAINED WITHIN THE PATIENT. THE RETAINED PORTION WAS LEFT IN PLACE."
Patient problems: Foreign Body In Patient
MAUDE report 11302045 ↗MalfunctionSep 29, 2020Break; Break
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT UPON REMOVAL OF THE PERIFLEX EPIDURAL CATHETER, THERE WAS APPROXIMATELY 1CM OF CATHETER TIP RETAINED. NO INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 10603353 ↗MalfunctionSep 29, 2020Break; Break
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT UPON REMOVAL OF THE PERIFLEX EPIDURAL CATHETER, THERE WAS APPROXIMATELY 4-5CM OF CATHETER TIP RETAINED. NO INJURY REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 10603291 ↗MalfunctionFeb 12, 2020Break; Break
PER MEDWATCH NUMBER MW5091658. IT WAS REPORTED THAT THE EPIDURAL CATHETER BROKE, LEAVING 12CM OF EPIDURAL CATHETER IN PATIENT. NO INJURY REPORTED. PLEASE NOTE: THIS REPORT IS BEING RESUBMITTED. THE MFR REPORT NUMBER (2523676-0190-00240) THAT WAS ORIGINALLY SUBMITTED ON 13-JAN- 2020 WAS INCORRECT. THE CORRECT MFR REPORT NUMBER IS 2523676-2019-00240.
Patient problems: Foreign Body In Patient
MAUDE report 9699558 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page