Design Options® 555449Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964315794), received between Mar 15, 2023 and Mar 15, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• MalfunctionMar 15, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: PER (B)(4): DESCRIPTION: DURING EPIDURAL PLACEMENT, THE TIP OF THE LIDOCAINE NEEDLE BROKE OFF. THE PATIENT WAS RECEIVING LIDOCAINE PRIOR TO PLACEMENT OF AN EPIDURAL DURING LABOR AND DELIVERY. MD WAS ABLE TO PROCEED WITH THE EPIDURAL AS PLANNED. NO INTERVENTION. PATIENT HAS HAD MULTIPLE FOLLOW UP VISITS DUE TO SYMPTOMS ASSOCIATED WITH THE FOREIGN BODY, WITH A PLAN TO UNDERGO SURGICAL REMOVAL OF THE NEEDLE TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 16544513 ↗