Perifix® 332202Recalls & reported problems

B. Braun Medical Inc. · PERIFIX® Continuous Epidural Set 17 Ga. x 3 1/2 in. (90mm) Tuohy Needle Set with 20 Ga. Closed Tip Nylon Catheter · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964178108), received between Mar 4, 2025 and Mar 4, 2025 — classified as 1 injury.

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.

InjuryMar 4, 2025Break; Break
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: THE CATHETER WAS PLACED AT L3/4 AND BROKE DURING REMOVAL. CT EXAM WAS PERFORMED. DESCRIPTION OF THE PATIENT EVENT: DISTAL PORTION BROKE OFF, LEFT IN THE PATIENT CT SHOWED NO EVIDENCE OF ANY FOREIGN BODY CONTACTED MED AFFAIRS PROVIDER GOING TO GET MRI AND IF DOESN'T SHOW ANYTHING LIKE CT THEN WILL FOLLOW CLINICAL SYMPTOMS WITHOUT IMMEDIATE INTERVENTION.
Patient problems: Foreign Body In Patient
MAUDE report 21514860 ↗

Device details

UDI-DI	`04046964178108`
Brand	Perifix®
Model	332202
Company	B. Braun Medical Inc.
Product code	OGE · Epidural anesthesia kit
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 24, 2020

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

A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

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All Epidural anesthesia kit devices →

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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