Perifix® 339190Recalls & reported problems

B. Braun Medical Inc. · CE18TKON PERIFIX ONE EPID FULL TRY NRFIT · 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 04046964941450), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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

Deflation Problem1

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.

MalfunctionDec 13, 2024Deflation Problem; Deflation Problem
ACCORDING TO THE COMPLAINANT AN EPIDURAL CATHETER PLACEMENT WAS PERFORMED ON THE NIGHT ON (B)(6) 2024. THE PLACEMENT WAS WITHOUT AN ISSUE. ONE PUNCTURE, CATHETER INSERTION WITHOUT DIFFICULTY, EFFECTIVE EPIDURAL ANALGESIA. REPORTEDLY THE CATHETER WAS REMOVED WITHOUT DIFFICULTY OR TRACTION. UPON REMOVAL THE DEVICE WAS MISSING 5 MILLIMETERS (MM) AT THE END OF THE CATHETER. AN ULTRASOUND AND CT SCAN WERE PERFORMED AND NOTHING WAS VISIBLE. THE FRAGMENT REMAINED IN THE PATIENT'S EPIDURAL SPACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20926654 ↗

Device details

UDI-DI	`04046964941450`
Brand	Perifix®
Model	339190
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	Jun 16, 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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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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