Design Options® 552102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964843846), received between Jun 29, 2017 and Sep 25, 2019 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 25, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED: DURING THE COURSE OF LABOR AND IN ANTICIPATION OF A DELIVERY, AN EPIDURAL WAS PLACED IN THE PATIENT'S BACK. THE PATIENT DELIVERED A FULL-TERM BABY AT (B)(6) ON (B)(6) 2017. PATIENT WAS DISCHARGED HOME ON (B)(6) 2017. ON (B)(6) 2017, PATIENT BEGAN RUNNING A FEVER AND EXPERIENCING PAIN IN HER LEG. THE PAIN CONTINUED TO INCREASE AND RADIATED DOWN HER LEGS AND INTO HER HIPS AND BACK TO THE POINT THAT, BY (B)(6) SHE WAS SHAKING AND COULD NOT WALK. ON (B)(6) 2017, THE PATIENT UNDERWENT SURGERY DUE TO A RUPTURED ABSCESS IN HER SPINE CAUSED BY THE CONTAMINATED EPIDURAL INSTRUMENTATION USED ON (B)(6) 2017.

  Patient problems: Abscess

  MAUDE report 9115447 ↗
• MalfunctionJun 29, 2017Break; Break

  AS PER MEDWATCH NUMBER: MW5069695. PATIENT STATUS POST RIGHT CHEST WALL RESECTION. ANESTHESIA TO PLACE EPIDURAL FOR CONTROL. PRESSURE TEST USED AND WHEN EPIDURAL CATH WAS ATTEMPTED TO BE PLACED IT WOULD NOT ADVANCE. WHEN REMOVED FROM NEEDLE IT WAS FRAYED AND BROKEN IN TWO. NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6677746 ↗