PENCAN® 333868Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04046964180866), received between Jan 26, 2018 and Aug 19, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50321715 ↗
• MalfunctionAug 19, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50321713 ↗
• MalfunctionMar 10, 2026Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: FOREIGN OBJECT OBSERVED IN THE SYRINGE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562864 ↗
• MalfunctionOct 23, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED A NEEDLE BREAK. ALTHOUGH REQUESTED, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE FOR THIS EVENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372245 ↗
• MalfunctionOct 15, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: "DURING THE ATTEMPT TO PLACE PRESERVATIVE FREE MORPHINE IN PATIENTS INTRATHECAL SPACE THE ANESTHESIA TEAM NOTED A PIECE OF THE NEEDLE MISSING. THEY DID NOT FEEL ANY RESISTANCE WHILE WITHDRAWING THE NEEDLE. THE DECISION WAS MADE TO HAVE THE FOREIGN BODY REMOVED SURGICALLY." THIS EVENT HAPPENED IN THE PRE-OP AREA, AND THEN THE BROKEN OFF PIECE WAS SURGICALLY REMOVED IN THE OPERATING ROOM. THE XRAY SUGGESTS THERE WAS SOME BEND TO THE NEEDLE IN SITU IN THE PATIENT'S BACK. IT IS UNCLEAR IF THERE WAS ADDITIONAL BEND FROM THE SURGICAL EXCISION.

  Patient problems: Foreign Body In Patient

  MAUDE report 23295735 ↗
• MalfunctionApr 21, 2025Device Contaminated During Manufacture or Shipping

  UPON OPENING THE TRAY PACKAGING, IT WAS DISCOVERED THAT THE TAPE THAT IS USED TO SEAL THE BLUE WRAP AROUND THE TRAY WAS CONTAMINATED WITH GRAY MATERIAL (? DUST). WAS NOT USED / NO PT (PATIENT) HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872518 ↗
• MalfunctionJan 26, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: PER CALL WITH CUSTOMER, A SYRINGE IN THE KIT HAD A PIECE OF CARDBOARD IN IT. THE SYRINGE COULD NOT BE USED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587133 ↗
• MalfunctionJul 12, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: THE ANESTHESIOLOGIST WAS USING THIS ON A PATIENT AND WHILE THEY WERE TAKING THE NEEDLE OUT THE NEEDLE FELL OUT OF PLACE. LUCKILY, IT DID NOT GET STUCK IN THE PATIENT. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17307652 ↗
• MalfunctionSep 14, 2022Break; Break

  AS PER MEDWATCH NUMBER MW5111600: DESCRIPTION: PROCEEDED TO INSERT SPINAL NEEDLE INTO LUMBAR AREA AND THE NEEDLE TIP BROKE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 15416617 ↗
• MalfunctionFeb 21, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: ANESTHESIOLOGIST WAS ATTEMPTING TO ADMINISTER SPINAL ANESTHESIA TO PATIENT FOR A CESAREAN SECTION. STYLET REMOVED FROM SPINAL NEEDLE WITHOUT INCIDENT. MINIMAL CEREBROSPINAL FLUID RETURN FROM NEEDLE BUT WITHOUT CONTINUOUS FLOW. NEEDLE REMOVED WITH INTRODUCER AND APPROX. 3 CM. TIP OF NEEDLE NOTED TO BE MISSING. ABDOMINAL X-RAY- SHOWED RADIOPAQUE FOREIGN BODY AT L3. CT LUMBAR SPINE, CONFIRMED FOREIGN BODY AT L3. ANESTHESIA ROUTE CONVERTED TO GENERAL FOR C/SECTION. LATER THAT DAY, PATIENT WAS TAKEN TO OPERATING ROOM FOR REMOVAL OF FOREIGN BODY (NEEDLE TIP) FROM DEEP LUMBAR SPINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13567729 ↗
• MalfunctionFeb 21, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: ANESTHESIOLOGIST WAS ATTEMPTING TO ADMINISTER SPINAL ANESTHESIA TO PATIENT FOR A CESAREAN SECTION. STYLET REMOVED FROM SPINAL NEEDLE WITHOUT INCIDENT. MINIMAL CEREBROSPINAL FLUID RETURN FROM NEEDLE BUT WITHOUT CONTINUOUS FLOW. NEEDLE REMOVED WITH INTRODUCER AND APPROX. 3 CM. TIP OF NEEDLE NOTED TO BE MISSING. ABDOMINAL X-RAY- SHOWED RADIOPAQUE FOREIGN BODY AT L3. CT LUMBAR SPINE, CONFIRMED FOREIGN BODY AT L3. ANESTHESIA ROUTE CONVERTED TO GENERAL FOR C/SECTION. LATER THAT DAY, PATIENT WAS TAKEN TO OR FOR REMOVAL OF FOREIGN BODY (NEEDLE TIP) FROM DEEP LUMBAR SPINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13567481 ↗
• MalfunctionNov 17, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE SPINAL NEEDLE BROKE OFF INSIDE OF A PATIENT. CRNA WAS PLACING A SPINAL IN ANTICIPATION OF A FOOT SURGERY. HE ENCOUNTERED BONE WHEN HE WENT TO PLACE THE SPINAL NEEDLE. UPON REMOVING THE SPINAL NEEDLE, A TWO CM PORTION BROKE OFF. A SECOND SPINAL WAS PLACED FOR THE SURGERY TO BE ABLE TO BE COMPLETED. THE CHIEF OF ANESTHESIA AND A NEUROSURGEON WERE CONSULTED. IMAGING OF THE AREA OCCURRED AFTER COMPLETION OF THE PREVIOUSLY SCHEDULED FOOT SURGERY THE PATIENT WAS BEING ANESTHETIZED FOR. IMAGINING REVEALS A 2CM PORTION OF THE NEEDLE LEFT OF THE L4 SPINAL PROCESS THAT DOES NOT EXTEND INTO THE SPINAL CANAL. THE PATIENT WAS DISCHARGED TO HOME AFTER HAVING BEEN SEEN BY NEUROSURGERY WITH INSTRUCTIONS TO BE SEEN IN HIS OFFICE FOR A TWO MONTH FOLLOW UP. THE 2CM PORTION OF THE NEEDLE WAS RETAINED IN THE PATIENT'S BODY AS THE NEUROSURGEON DISCUSSED THAT THERE WAS A VERY LOW CHANCE OF MIGRATION OF THE NEEDLE TIP AND ANY ASSOCIATED ADVERSE EFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12832749 ↗
• MalfunctionSep 17, 2021Break; Break

  AS REPORTED BY THE USER FACILITY: PER CONVERSATION, THE FACILITY IS REPORTING AN INCIDENT ABOUT 10 DAYS AGO WHERE A (B)(6) Y.O. MALE WAS UNDERGOING A PROCEDURE WITH OUR PRODUCT REF (B)(4) LOT 0061785913 WHEN THE 24G X 4 IN PENCAN SPINAL NEEDLE BROKE OFF AND THE TIP WAS RETAINED BY THE PATIENT. THE PATIENT REQUIRED TRANSFER TO A DIFFERENT FACILITY FOR POSSIBLE REMOVAL. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 12490751 ↗
• MalfunctionMar 26, 2020Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS STATED THAT THE NEEDLE BENT DURING INSERTION. WHEN THE NEEDLE WAS REMOVED A BENT WAS OBSERVED AND UPON TOUCHING THE NEEDLE, IT BROKE OFF FROM THE HUB. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9884787 ↗
• MalfunctionMar 6, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT DIRT WAS SEEN ON THE SYRINGE. NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9800824 ↗
• MalfunctionNov 14, 2019Break; Break

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTS: SPINAL NEEDLE BROKE OFF AND WAS RETAINED IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9323810 ↗
• MalfunctionJan 26, 2018Break; Break

  AS REPORTED BY THE USER FACILITY: SPINAL NEEDLE TIP SNAPPED OFF DURING INSERTION. NEEDLE TIP REMAINED IN PATIENT, REST OF NEEDLE REMOVED. NEW TRAY OBTAINED AND SPINAL DONE WITHOUT FURTHER INCIDENT. LIMITED INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 7221323 ↗