Design Options® 560074Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964317873), received between May 3, 2023 and May 3, 2023 — classified as 1 injury.

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

1 FDA recall record name this device's identifier, 1 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. May 6, 2026Open, Classified

   These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.

   Z-2278-2026 · Root cause: Under Investigation by firm · 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.

• InjuryMay 3, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THE NEEDLE BROKE IN PATIENT'S BACK. THE NEEDLE WAS RETAINED IN THE PATIENT'S BACK REQUIRING SURGERY TO REMOVE IT. FOREIGN OBJECT REMOVED FROM THE L3 AND L4 LEVEL, LAMINOFORAMINOTOMY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16864649 ↗