Design Options® 560606Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964320958), received between Feb 9, 2022 and Feb 9, 2022 — 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.

• MalfunctionFeb 9, 2022Break; Break

  AS PER MEDWATCH NUMBER MW5106280; SPINAL NEEDLE BROKE WHILE BEING USED FOR SPINAL ANALGESIA. THE PATIENT WAS A (B)(6) MALE THAT WAS SCHEDULED TO HAVE A RIGHT TOTAL KNEE ARTHROPLASTY. DIAGNOSIS IS: PRIMARY OSTEOARTHRITIS OF BOTH KNEES. THE PLAN FOR ANESTHESIA WAS A PERIPHERAL NERVE BLOCK AND A SPINAL BLOCK. THE NEEDLE BROKE DURING THE SPINAL BLOCK. A SECOND SURGERY NEEDED TO BE PLANNED TO REMOVE THE NEEDLE. THERE WAS SOME DELAY BECAUSE A SPINAL SURGEON AT 2 DIFFERENT HOSPITALS WERE CONSULTED PRIOR TO THE SURGERY. HE ENDED UP STAYING A DAY IN THE HOSPITAL FOR THE SPINAL SURGERY TO REMOVE THE NEEDLE. THE PATIENT WAS UNABLE TO HAVE HIS KNEE SURGERY AND IT WAS RESCHEDULED FOR A LATER DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13498409 ↗