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Design Options® 530164Recalls & reported problems

B. Braun Medical Inc. · Combined Spinal/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 04046964808883), received between May 16, 2023 and May 16, 2023 — 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.

  • MalfunctionMay 16, 2023Break; Break

    AS REPORTED BY THE USER FACILITY: DESCRIPTION OF THE PATIENT EVENT - PLACING AN OB LABOR EPIDURAL ON (B)(6) 2023 AND HAD EVENT WHERE THE EPIDURAL CATHETER SHEARED DURING THE PROCESS. THE RETAINED PIECE IN THE PATIENT'S BACK IS ABOUT 8CM LONG. NEUROSURGERY SAW THE PATIENT AND RECOMMENDED AN MRI TO DELINEATE THE LOCATION OF THE SHEARED CATHETER.

    Patient problems: Foreign Body In Patient

    MAUDE report 16943320 ↗

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Sources and updates

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