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Design Options® 560646Recalls & reported problems

B. Braun Medical Inc. · Spinal Tray · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964809101), received between Jan 25, 2021 and Jan 25, 2021 — 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

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 25, 2021Break; Break

    AS REPORTED BY THE USER FACILITY: "WE HAD A PATIENT YESTERDAY THAT CAME IN FOR A KNEE SCOPE. THE PATIENT WAS RECEIVING A SPINAL WITH A MEDICAL STUDENT AND THE ATTENDING DOCTOR. DURING INSERTION, THE NEEDLE BROKE OFF INSIDE OF THE PATIENT. ABOUT AN INCH OF NEEDLE WAS RETAINED. THE PATIENT WAS CONVERTED TO GENERAL ANESTHESIA AND THEY WENT AHEAD WITH THE PROCEDURE. IN THE PACU, THE PATIENT WAS TAKEN FOR A CT SCAN TO CONFIRM THE NEEDLE TIP PLACEMENT. THE CT REPORT SAID THAT THE NEEDLE TIP WAS BENT. THE NEEDLE WAS INSERTED IN L3 AND THE TIP WAS BENT UP TOWARDS L2. LATER IN THE DAY, THE PATIENT WAS TAKEN BACK TO THE OR FOR RETRIEVAL OF THE NEEDLE TIP. THIS WAS SUCCESSFUL AND THE PATIENT WAS ADMITTED. PER THE PATIENTS CHART, SHE HAS NO DEFECTS AS A RESULT OF THE INCIDENT."

    Patient problems: Foreign Body In Patient

    MAUDE report 11223785 ↗

Other Spinal anesthesia kit devices

All Spinal anesthesia kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.