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Design Options® 555296Recalls & reported problems

B. Braun Medical Inc. · Continuous Epidural Tray · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964314971), received between May 2, 2019 and Jun 12, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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

  • Detachment of Device or Device Component3

Patient problems

  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 12, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    AS PER MEDWATCH NUMBER (B)(4). THE CLAMP DOESN'T CLAMP. NO INJURY REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8690979 ↗
  • MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    AS PER USER FACILITY VIA MW (B)(4), EVENT 1: EPIDURAL CATHETER DISCONNECTED WHERE THE EPIDURAL TUBE CONNECTS TO THE CLEAR CATHETER CONNECTOR CLAMP STYLE PROVIDED IN THE EPIDURAL KITS. THIS HAPPENED TWICE ON THIS PATIENT. DUE TO THIS INCIDENT THE PATIENT EXPERIENCED UNNECESSARY PAIN. NO PATIENT INJURY. THIS REPORT IS FOR THE FIRST OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8574211 ↗
  • MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    AS PER USER FACILITY VIA MW (B)(4), EVENT 2: EPIDURAL CATHETER DISCONNECTED WHERE THE EPIDURAL TUBE CONNECTS TO THE CLEAR CATHETER CONNECTOR CLAMP STYLE PROVIDED IN THE EPIDURAL KITS. THIS HAPPENED TWICE ON THIS PATIENT. DUE TO THIS INCIDENT THE PATIENT EXPERIENCED UNNECESSARY PAIN. NO PATIENT INJURY. THIS REPORT IS FOR THE SECOND OCCURRENCE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8574208 ↗

Other Epidural anesthesia kit devices

All Epidural anesthesia kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.