Espocan® 333196 (UDI 04046955899531)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046955899531), received between Jan 7, 2025 and Jan 7, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 18, 2025Open, Classified

   Potential for the lid of the catheter connector to be in the incorrect position.

   Z-0122-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: PHYSICIAN REPORTED MULTIPLE PROBLEMS WITH ABOVE-MENTIONED PRODUCT CLAMP0 NOT CLOSING PROPERLY, DIFFICULTY WITH MEDICATION DELIVERY-DIFFICULT TO PUSH, AND CLAIM NOT FUNCTIONING PROPERLY RESULTING IN RETAINED OBJECT. UNFORTUNATELY LOT NUMBERS WERE NOT CAPTURED AS PRODUCT WAS DISCARDED. VPCO REEDUCATED ON SAVINGS PRODUCTS TO ROOT CAUSE AND APPROPRIATELY REPORT. PHYSICIAN ADVISED WILL UPTRAIN TEAM ON APPROPRIATE HANDLING OF FAILED PRODUCTS TO CAPTURE LOT NUMBER TO ROOT CAUSE.. ISSUES STARTED IN JUNE 2024 WITH DIFFICULTY IN PUSHING MEDICATION. DR. HASSAN IQBAL CONTACTED VENDOR TO REPORT AND VENDOR REVAMPED KIT WITH RESOLUTION. NO REPEAT OCCURRENCES REPORTED UNTIL APPROXIMATELY OCTOBER WHEN SEVERAL END-USERS REPORTED DIFFICULTY WITH PUSHING MEDICATION. DR. IQBAL PERSONALLY LED CASE AND REPLICATED DIFFICULTY WITH PUSHING MEDICATIONS. ON A SEPARATE CASE ON 12/17/24, MORBIDLY OBESE PATIENT USED SAME EPIDURAL TRAY AND CATHETER SHREDDED AND RETAINED BODY LEFT IN PATIENT. REPORTED TO SUPPLY CHAIN AND VENDOR CONTACTED. VENDOR OFFERED TO REPLACE CATHETERS. SUPPLY CHAIN DIRECTOR REPORTED TO VP CLINICAL OPERATIONS. VP ADVISED PATIENT SAFETY OFFICER AND ENTERED PRO

  Patient problems: Foreign Body In Patient

  MAUDE report 21091937 ↗