Design Options® 560657Recalls & reported problems
B. Braun Medical Inc. · HOSPITAL FOR SPECIAL SURGERY-SPINAL TRAY · Class 2
- 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 04046955331802), received between May 1, 2026 and May 1, 2026 — 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.
Reports received per month
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.
MalfunctionMay 1, 2026Break
AS REPORTED BY THE USER FACILITY: YELLOW INTRODUCER BROKE IN A PATIENTS BACK.
Patient problems: Foreign Body In Patient
MAUDE report 25056311 ↗
Other Spinal anesthesia kit devices
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- PENCAN® 333868B. Braun Medical Inc. · Spinal anesthesia kit1 recall17 reports
- Design Options® 560603B. Braun Medical Inc. · Spinal anesthesia kit1 recall5 reports
- PENCAN® 333865B. Braun Medical Inc. · Spinal anesthesia kit1 recall4 reports
- PENCAN® 333871B. Braun Medical Inc. · Spinal anesthesia kit1 recall2 reports
- Design Options® 560074B. Braun Medical Inc. · Spinal anesthesia kit1 recall1 report
- Design Options® 560533B. Braun Medical Inc. · Spinal anesthesia kit1 recall1 report
- Design Options® 560606B. Braun Medical Inc. · Spinal anesthesia kit1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.