Design Options® 530112Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964305627), received between Sep 29, 2020 and Sep 29, 2020 — 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.

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.

• MalfunctionSep 29, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE EPIDURAL CATHETER WAS SHEARED OFF DURING PLACEMENT, 4.5 CM FRAGMENT PRESUMED TO REMAIN IN PATIENT. A CT SCAN WAS DONE BUT CATHETER COULD NOT BE VISUALIZED. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 10603295 ↗