Design Options® 530192Recalls & reported problems

B. Braun Medical Inc. · SESK JACKSON MADISON CNTY GEN HOSP · 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 04046955589340), received between Oct 16, 2024 and Oct 16, 2024 — 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

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

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.

MalfunctionOct 16, 2024Break; Break
AS REPORTED, CATHETER SHEAR OFF OF THE WIRE AND THE WIRE ITSELF BECOME LODGED IN A PATIENT'S BACK. PATIENT IS HAVING A XRAY TO BE SURE THAT EVERYTHING IS OUT OF HER BACK AND RESULTS ARE PENDING AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 20467208 ↗

Device details

UDI-DI	`04046955589340`
Brand	Design Options®
Model	530192
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	May 4, 2020

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

A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent to the intrathecal space and to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent, and 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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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