Design Options® 530184Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046955156528), received between Sep 3, 2020 and Sep 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Jan 29, 2026Open, Classified

   B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.

   Z-2267-2026 · Root cause: Process control · FDA record ↗

2. Sep 18, 2025Open, Classified

   Potential for the lid of the catheter connector to be in the incorrect position.

   Z-0124-2026 · Root cause: Process control · FDA record ↗

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 3, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A "TEAR/BREAK IN EPIDURAL FX CATHETER WAS OBSERVED DURING REMOVAL. NO INJURY REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10487844 ↗