PENCAN® 333871Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964180903), received between Feb 21, 2017 and Nov 23, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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-2276-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2022Break; Break

  DETAILED INQUIRY DESCRIPTION: 27G PENCAN NEEDLE SNAPPED WHILE INSIDE OF A PATIENT NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15853987 ↗
• MalfunctionFeb 21, 2017Break; Break

  AS REPORTED BY USER FACILITY: THE SPINAL NEEDLE BROKE OFF INTO THE PATIENT. PATIENT HAD TO UNDERGO ADDITIONAL SURGERY TO RETRIEVE THE BROKEN OFF PIECE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6345642 ↗