E-Cath acc. Tsui 251285-40E (UDI 14048223037345)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14048223037345), received between Feb 13, 2019 and Oct 13, 2020 — classified as 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2020Break; Break

  (B)(4). INITIAL REPORTERS NARRATIVE:"MISSING PIECE ON THE NERVE BLOCK CATHETER ALLOWING THE EXTERNAL CATHETER TO SLIDE ON THE NEEDLE RESULTING IN SHEARING OF THE CATHETER. ORIGINAL INTENDED PROCEDURE: NOT KNOWN ;USER PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)." INITIAL REPORTER´S REPORT NUMBER: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 10668316 ↗
• MalfunctionFeb 13, 2019Component Missing; Component Missing

  IRN# (B)(4). MEDSUN USER REPORT NUMBER: (B)(4). EVENT TITLE: TUBING MISSING FROM PACKAGE THAT CONNECTS TO NEEDLE -------------------------------------- DESCRIBE THE EVENT OR PROBLEM: STERILE CATHETER KITS MISSING THE TUBING THAT CONNECTS ON THE LUER LOCK PART ON THE NEEDLE (NOT THE TUBING ATTACHED TO THE INNER CATHETER.) -------------------------------------- WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8334597 ↗