Perifix® 332084Recalls & reported problems

B. Braun Medical Inc. · PERIFIX® 18 Ga. x 3-1/2 in. (90 mm) Hustead, PERIFIX 20 Ga. Closed Tip SoftTip Catheter, 5 mL Glass Luer Lock LOR Tray (Kit) · Class 2

All models of Perifix (57)

Data updated Oct 16, 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 04046964177309), received between Dec 17, 2025 and Dec 17, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

MalfunctionDec 17, 2025Break; Break
AS BY MEDSUN NUMBER (B)(4): DESCRIBE THE EVENT OR PROBLEM: ABLE TO GET TO INTRATHECAL SPACE WITH CSF (CEREBRAL-SPINAL FLUID) COMING BACK IN TOUHY NEEDLE ON FIRST ATTEMPT. CATHETER THREADED WITH NO RESISTANCE. ON WITHDRAWAL OF TOUHY NEEDLE, CATHETER TEARED AT 21 CM MARK. WENT TO REMOVE IT AND CATHETER PIECE HAD MIGRATED INTO THE THECAL SAC SO CASE WAS ABORTED. CATHETER PIECE REMAINS IN PATIENT BODY.
Patient problems: Foreign Body In Patient
MAUDE report 23833258 ↗

Device details

UDI-DI	`04046964177309`
Brand	Perifix®
Model	332084
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	Feb 17, 2021

Device type (GMDN): Epidural anaesthesia set, medicated

A collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal 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 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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