PENCAN® 333865Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964180804), received between Nov 18, 2019 and Nov 26, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Break; Break

  ACCORDING TO THE EVENT DESCRITPION: A PATIENT WITH CHRONIC AND COMPLEX ANAL FISTULA FOR SEVERAL YEARS. THE PATIENT WAS OPERATED ON FOR PROCTOLOGICAL EXPLORATION. DURING PUNCTURE FOR SPINAL ANESTHESIA, WHEN THE NEEDLE WAS WITHDRAWN, THE LAST TWO CENTIMETERS OF THE NEEDLE WERE FOUND TO BE MISSING: THE NEEDLE HAD BROKEN OFF, WITH A CLEAN CUT APPROXIMATELY 2 CENTIMETERS (CM) FROM THE TIP. THE MISSING END OF THE NEEDLE REMAINED IN THE PATIENT. SPINAL ANESTHESIA WAS DISCONTINUED AND THE PATIENT SWITCHED TO A MUCH HEAVIER GENERAL ANESTHESIA, WHICH ENTAILED CONSIDERABLE RISK FOR THE PATIENT. FOLLOWING NEUROSURGICAL ADVICE AND A CT SCAN, THE NEEDLE TIP IN THE PATIENT WILL NOT BE REMOVED UNLESS COMPLICATIONS ARISE. INCREASED INFECTIOUS SURVEILLANCE. REPORTEDLY THE BROKEN PART WAS RECOVERED. THE PATIENT'S BMI WAS 25.95 KG/M² AT THE TIME OF SURGERY. OPERATIVE TIME WAS PROLONGED, AND THE PATIENT HAD TO BE RE-OPERATED TO REMOVE THE REMAINING PART OF THE NEEDLE. THE INTRODUCER WAS IN PLACE AT THE TIME OF PUNCTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20789728 ↗
• InjuryNov 1, 2024Break; Break

  ACCORDING TO THE EVENT DESCRIPTION THERE WAS AN ACCIDENTAL AND UNPREDICTABLE BREAKAGE OF A SPINAL NEEDLE WITH RETENTION OF ITS DISTAL END IN THE SUBCUTIS. REPORTEDLY THERE WAS AN INTERVENTION TO REMOVE DISTAL PART IN THE SUBCUTIS.

  Patient problems: Discomfort

  MAUDE report 20591657 ↗
• InjurySep 13, 2024Break; Break

  ACCORDING TO THE EVENT DESCRIPTION: DURING AN ATTEMPT TO PERFORM SPINAL ANAESTHESIA ON A DIFFICULT PATIENT AFTER NEEDLE EXTRACTION, THE NEEDLE IS FOUND TO BE DAMAGED. THE NEEDLE IS BROKEN APPROXIMATELY 5 CM FROM THE BEVEL. THE PATIENT WAS THEN SENT TO RADIOLOGY WHERE SHE UNDERWENT X-RAY AND CT SCAN WHICH REVEALED THE PRESENCE OF THE STUMP AT THE LEVEL OF THE SPINAL PROCESS. ARRANGEMENTS ARE THEN MADE WITH THE RELEVANT NEUROSURGERY DEPARTMENT AND TRANSFER IS ARRANGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20211300 ↗
• MalfunctionNov 18, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT UPON REMOVAL, THE PENCAN NEEDLE BROKE OFF IN PATIENT'S BACK. DURING A TELEPHONE CONVERSATION THE NURSE MANAGER IT WAS STATED THAT," THE BROKEN NEEDLE TIP WAS NOT RECOVERED. THE PATIENT DID NOT RECEIVE SURGICAL INTERVENTION AT THE TIME OF THE EVENT, OR AS OF CURRENT DATE. IT WAS DECIDED TO SEND THE PATIENT FOR NEURO-SURGERY CONSULT, AND OBSERVE. NO COMPLICATIONS AS OF TODAY."

  Patient problems: Foreign Body In Patient

  MAUDE report 9335006 ↗