Design Options® 560533Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964319518), received between Oct 16, 2019 and Oct 16, 2019 — classified as 1 malfunction.

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.

• MalfunctionOct 16, 2019Break; Break

  AS PER MEDWATCH REPORT NUMBER (B)(4). EVENT DESCRIPTION: PATIENT SITTING FOR SPINAL ANESTESIA, NEEDLE WAS INTRODUCED TO SKIN WHEN NEEDLE REMOVED, A PORTION OF NEEDLE WAS BROKEN OFF. EPIDURAL PLACED BY ANESTESIA. STAT X-RAY ORDERED BY ANESTHESIA TO BE DONE IN PACU. MD AT BEDSIDE TO EXPLAIN COMPLICATION TO PATIENT. PATIENT CAME FROM TRIAGE FOR A C-SECTION. SHE HAD A BIOPHYSICAL PROFILE (BPP) OF 6/8. HX OF HEP B AND SUBSTANCE ABUSE. PHYSICAN ATTEMPTED TO PLACE A SPINAL AND HALF OF THE NEEDLE BROKE OFF IN THE PATIENT'S BACK. NURSING CARE RENDERED APPROPRIATELY. PHYSICIAN ORDERED A STAT X-RAY. THE PATIENT GOT AN EPIDURAL AND WAS STABLE. SHE DID NOT FEEL ANY PAIN AND PHYSICIAN EXPLAINED EVERYTHING TO HER. AN X-RAY WAS DONE IN PACU. A NEURO CONSULT WILL BE DONE. THIS CASE WAS REVIEWED IN DETAIL WITH PHYSICIAN. SHE STATES THAT SHE ONLY PASSED THE SPINAL NEEDLE ONCE AND THAT IT WAS ATRAUMATIC. DENIES BONY CONTACT. IT WAS REMOVED ALONG WITH THE INTRODUCER NEEDLE AS ONE BECAUSE SHE INTENDED TO DO A CONTINUOUS SPINAL/EPIDURAL TECHNIQUE DUE TO THE AMOUNT OF OVERLYING SOFT TISSUE. THERE IS NO OBVIOUS REASON WHY THIS NEEDLE FAILED. IT DOES NOT APPEAR TO BE RELATED TO TECHNIQUE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9196915 ↗