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Design Options® 551366Recalls & reported problems

B. Braun Medical Inc. · Single Dose 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 04046964186257), received between Sep 28, 2020 and Sep 28, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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

  • Contamination /Decontamination Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 28, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE HYPODERMIC NEEDLE IN THE TRAY LEFT A BLACK MARK ON THE PATIENT'S BACK WHEN REMOVED. THERE WERE NO SIGNS OF AN ALLERGIC REACTION (REDNESS, SWELLING, RASH) AT THE ENTRY SITE AFTER REMOVAL. NO INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10592460 ↗

Other Epidural anesthesia kit devices

All Epidural anesthesia kit devices →

Sources and updates

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