Design Options® 552030Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964312106), received between Feb 11, 2020 and Feb 11, 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.

• MalfunctionFeb 11, 2020Break; Break

  PER MEDWATCH NUMBER (B)(4): ANESTHESIOLOGIST WAS PLACING THE EPIDURAL FOR THE PATIENT AT BEDSIDE WHEN THE EPIDURAL CATHETER BROKE, LEAVING 5.5-6 CM OF THE CATHETER IN THE PATIENT'S EPIDURAL SPACE. ANESTHESIOLOGIST COVERED THE INSERTION SITE WITH A GAUZE. HE CONSULTED WITH OTHER ANESTHESIOLOGIST AND NEUROSURGERY. A SPINAL BLOCK WAS PERFORMED. PATIENT WAS ADVISED THAT NEUROSURGERY WOULD BE CONSULTING HER DURING HER HOSPITAL STAY. PATIENT REMAINED STABLE. LOWER LUMBER X-RAY WAS TAKEN. EPIDURAL CATHETER WAS NOT VISUALIZED. AFTER EVALUATION BY NEUROSURGERY, NO INTERVENTION RECOMMENDED AT THIS TIME. THE PATIENT WILL FOLLOWED UP LATER THIS MONTH TO DISCUSS NECESSITY OF A CT SCAN FOR ACTUAL VISUALIZATION. NEUROSURGERY ONLY RECOMMENDS THIS SHOULD SHE WISH TO PROCEED WITH HAVING IT REMOVED. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9694004 ↗