Design Options® 530029Recalls & reported problems

B. Braun Medical Inc. · Combined Spinal/Epidural Tray · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964305245), received between Jun 24, 2024 and Jun 24, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Sep 18, 2025Open, Classified
Potential for the lid of the catheter connector to be in the incorrect position.
Z-0124-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

Break1

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.

MalfunctionJun 24, 2024Break; Break
AS REPORTED BY THE USER FACILITY: THEY PLACED A CSE LAST NIGHT IN THE OPERATING ROOM AND THE CATHETER WIRE WAS BROKEN AND UNABLE TO THREAD - ABLE TO THREAD UNTIL 14CM AND THEN UNABLE TO THREAD AND WE NOTICED THE CATHETER WIRE WAS BROKEN. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19593725 ↗

Device details

UDI-DI	`04046964305245`
Brand	Design Options®
Model	530029
Company	B. Braun Medical Inc.
Product code	OFT · Spinal epidural anesthesia kit
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jun 15, 2020

Device type (GMDN): Epidural/intrathecal anaesthesia set, non-medicated

A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe) and may include an epidural catheter for continuous-administration. This is a single-use device.

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