Design Options® 551875Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964308512), received between Jun 19, 2019 and Sep 23, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: THE CUSTOMER REPORTED A BROKEN OFF CATHETER WITH THE CATHETER TIP RETAINED. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15475155 ↗
• MalfunctionJun 19, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 1: END USER REPORTS ISSUES OF THE CATHETER BREAKING AT THE JUNCTION WITH THE ADAPTER TO THE INFUSION TUBING. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8714495 ↗
• MalfunctionJun 19, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 2: END USER REPORTS ISSUES OF THE CATHETER BREAKING AT THE JUNCTION WITH THE ADAPTER TO THE INFUSION TUBING. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8714492 ↗
• MalfunctionJun 19, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: EVENT 3: END USER REPORTS ISSUES OF THE CATHETER BREAKING AT THE JUNCTION WITH THE ADAPTER TO THE INFUSION TUBING. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8714491 ↗