Perifix® 339193Recalls & reported problems

B. Braun Medical Inc. · SD20TDN 20 GA SD EPIDURAL TRAY 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 04046964941511), received between Jan 16, 2025 and Jan 16, 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

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.

MalfunctionJan 16, 2025Break; Break
ACCORDING TO THE EVENT DESCRIPTION: THE DOCTOR INSERTED THE CATHETER AND FOUND THAT IT WAS PLACED TOO DEEPLY. THEN DOCTOR REMOVED CATHETER FROM THE PATIENT, AND IT WAS FOUND TO BE STRETCHED AND BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21167787 ↗

Device details

UDI-DI	`04046964941511`
Brand	Perifix®
Model	339193
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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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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