Espocan® 333151Recalls & reported problems

B. Braun Medical Inc. · ES1727L SPINAL/EPI SET FOR OBESE · Class 2

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 04046964593512), received between Oct 17, 2023 and Oct 17, 2023 — 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 17, 2023Break; Break
AS REPORTED BY THE USER FACILITY: EPIDURAL CATHETER INSERTION WAS UNEVENTFUL. UPON REMOVAL OF THE EPIDURAL, THE CATHETER FRACTURED, AND SOME PART OF THE CATHETER WAS RETAINED IN THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 17948488 ↗

Device details

UDI-DI	`04046964593512`
Brand	Espocan®
Model	333151
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	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 16, 2020

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

A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.