PENCAN® 333851Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 04046964180606), received between Apr 20, 2017 and Aug 7, 2026 — classified as 8 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Break” (35 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Break

  Patient problems: Foreign Body In Patient

  MAUDE report 50173285 ↗
• InjuryApr 27, 2026Break

  AS REPORTED BY THE USER FACILITY: THE PATIENT UNDERWENT A SCHEDULED CESAREAN SECTION (C-SECTION) ON (B)(6) 2026. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) AT APPROXIMATELY 07:35 AND POSITIONED FOR SPINAL ANESTHESIA. DURING PLACEMENT OF THE SPINAL ANESTHETIC, THE SPINAL NEEDLE BECAME LODGED IN THE PATIENT'S BACK AND COULD NOT BE REMOVED. THE NEEDLE SUBSEQUENTLY FRACTURED, LEAVING A PORTION RETAINED IN THE PATIENT. THE C-SECTION PROCEDURE WAS COMPLETED. A SURGICAL CONSULTATION WAS OBTAINED FOR REMOVAL OF THE RETAINED NEEDLE FRAGMENT. THE PATIENT WAS SCHEDULED TO RETURN TO THE OR FOR RETRIEVAL OF THE RETAINED DEVICE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24997985 ↗
• MalfunctionJan 22, 2026Break

  AS REPORTED BY THE USER FACILITY: DURING THE PROCEDURE, THE DISTAL END OF THE NEEDLE SEPARATED AND REMAINED IN THE PATIENT. ULTRASOUND GUIDANCE WAS USED TO LOCATE AND RETRIEVE THE FRAGMENT SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24157868 ↗
• MalfunctionNov 5, 2025Break; Break

  PRIOR TO SPINAL PLACEMENT PT ARCHED HER BACK WHEN SUBCUTANEOUS LOCAL WAS BEING PLACED. WHEN LOCAL NEEDLE WAS REMOVED IT APPEARS THAT THE TIP WAS BROKEN OFF AND REMAINS IN THE SUBQ TISSUE. SURGEON AWARE AND WILL PERFORM XRAY TO IDENTIFY NEEDLE TIP LOCATION. XRAY WAS PERFORMED SHOWING SMALL PIECE REMAINING IN SUBQ TISSUE. APPROXIMATELY 3MM OF THE NEEDLE IN THE SOFT TISSUE OF THE PATIENTS BACK. MANUFACTURER WAS NOTIFIED ON 10/17/2025. BRAUN TRAY: 333851 KIT, EXP DATE: 7/31/2027, LOT ##: 0667.

  Patient problems: Foreign Body In Patient

  MAUDE report 23476245 ↗
• MalfunctionSep 16, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: REPORTER NOTED THAT YOU CAN SEE RIGHT AWAY BUPIVACAINE CRYSTALLIZATION SEMI SOLID YELLOW TINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067595 ↗
• MalfunctionMay 9, 2025Break; Break

  AS PER MEDWATCH MW5168623: DESCRIBE EVENT OR PROBLEM: SPINAL NEEDLE FRACTURED DURING ATTEMPTED PLACEMENT OF SPINAL ANESTHESIA, 2.5 CM FRAGMENT RETAINED IN THE PATIENT'S BACK REQUIRING SURGICAL REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 21993549 ↗
• MalfunctionJan 31, 2025Break; Break

  AS PER MEDWATCH NUMBER MW5163775: DESCRIBE EVENT OR PROBLEM: PATIENT DELIVERED BY PRIMARY C/S THIS AM FOR ARREST OF DESCENT. EPIDURAL INEFFECTIVE. ATTEMPTED SPINAL ANESTHESIA PLACEMENT BY CRNA USING PENCAN SPINAL NEEDLE TRAY REF (B)(4), PRODUCT CODE P25BK, THE SPINAL NEEDLE BROKE OFF INSIDE OF THE PATIENT. IT WAS A 25GA X 3.5" (8.9CM) NEEDLE WITH 1.5" OF NEEDLE LEFT IN PATIENT. NEUROSURGEON CALLED IN TO REMOVE NEEDLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21287386 ↗
• InjuryDec 13, 2024Break; Break

  IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT A PENCAN® (MATERIAL 333851, LOT 0061946960) WAS BEING USED TO ADMINISTER ANETHESIA ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, SPINAL NEEDLE BROKE OFF IN LABORING PATIENTS BACK DURING THE SPINAL PROCEDURE.CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) AT BEDSIDE PLACING SPINAL FOR SCHEDULED REPEAT CAESAREAN SECTION (C/S). AFTER SUCCESSFUL PLACEMENT OF LOCAL ANETHESIA SPINAL NEEDLE WAS REMOVED AND FOUND TO HAVE A MISSING TIP. MASS DRUG ADMINISTRATION (MDA) NOTIFIED TO COME TO OPERATING ROOM (OR). WHEN C/S WAS COMPLETED CRNA ALERTED PATIENT AND OBSTETRICS (OB) PROVIDER AND XRAY WAS ORDERED STAT. CONFIRMED NEEDLE TIP WAS IN PATIENT'S BACK. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 20924571 ↗
• MalfunctionSep 25, 2024Break; Break

  AS STATED IN THE COMPLAINT DESCRIPTION: CUSTOMER COMPLAINT ADVOCATE SUMMARIZED PATIENT EXPERIENCE FROM DOCUMENT: DURING HIP REPLACEMENT SURGERY NEEDLE RETAINED IN PATIENT POST OPERATIVELY. AS A RESULT OF THE LEFT BEHIND INTRODUCER NEEDLE, PLAINTIFF BEGAN TO SUFFER PAIN AND IMPAIRMENT. AT FIRST, THE PLAINTIFF FELT AS THOUGH HE HAD BEEN SHOT WITH A BB. PROGRESSIVELY, PLAINTIFF'S PAIN, DISCOMFORT AND IMPAIRMENT BECAME WORSE. IN AN EFFORT TO DETERMINE THE SOURCE OF HIS PAIN, THE PLAINTIFF WAS WORKED UP FOR A CONTRALATERAL HIP REPLACEMENT. RADIOLOGY AND/OR CLINICALLY, THE HIP DID NOT JUSTIFY THIS OPERATION. PLAINTIFF CONTINUED TO SUFFER. BELIEVING THE PAIN MAY HAVE THEN BEEN SPINE RELATED, PLAINTIFF BEGAN A WORKUP FOR A SPINAL PROCEDURE. AS PART OF THAT WORKUP, PLAINTIFF WAS SENT FOR A MR IMAGING. THE MRI TECHNICIAN BEGAN THE STUDY BUT WAS IMMEDIATELY ALERTED BY ARTIFACT ON THE SCAN THAT PLAINTIFF HAD METAL IN HIS BODY AT THE SITE OF THE SCAN. THE POTENTIALLY DANGEROUS PROCEDURE WAS IMMEDIATELY STOPPED, AND THE PLAINTIFF WAS QUESTIONED AND DENIED HAVING ANY KNOWN METAL IN HIS LOW BACK OR SPINE. AN X-RAY WAS THEN TAKEN WHICH REVEALED THE LEFT BEHIND INTRODUCER NEEDLE FROM MONTHS BEFORE.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 20304290 ↗
• MalfunctionAug 27, 2024

  A 7% BUPIVACAINE FROM TRAY WAS NOT EFFECTIVE TO CONTROL PT'S PAIN.

  Patient problems: Pain

  MAUDE report 20090587 ↗
• MalfunctionMay 6, 2024Break; Break

  PER MEDWATCH NUMBER MW5152064: SPINAL ANESTHETIC. SMALL PORTION OF THE TIP OF THE SPINAL NEEDLE FROM THE SPINAL BLOCK BROKE. AND SUBSEQUENT XR SHOWS RETAINED FRAGMENT NEAR LUMBAR SPINOUS PROCESS. NO APPARENT HARM TO PATIENT AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 19247349 ↗
• MalfunctionJan 16, 2024

  PT REQUIRED AN URGENT C-SECTION DUE TO ARREST OF CERVICAL DILATATION. SPINAL FOR ANESTHESIA PERFORMED. PT WITH SOME PATCHY SENSATION. ADDITIONAL ANESTHETIC NEEDED. ANESTHESIOLOGIST STATES THAT IT HAD GOOD PLACEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18527619 ↗
• MalfunctionDec 20, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: ON (B)(6) 2022, DOCTOR ATTEMPTED TO ADMINISTER THE SPINAL BLOCK IN PATIENT'S LOWER BACK TWICE. DOCTOR USED A 25 G 3.5 CM PENCIL-TIP NEEDLE ON THE FIRST ATTEMPT. ON THE SECOND ATTEMPT, DOCTOR UTILIZED A 25G 4-INCH PENCAN BY B. BRAUN MEDICAL INC. WHEN ADMINISTERING THE SECOND SPINAL BLOCK, THE SPINAL NEEDLE TIP BROKE IN PATIENT'S LOWER LUMBAR SPINE. DOCTOR PROCEEDED WITH ADMINISTERING THE EPIDURAL AFTER FOUND THAT THE "SPINAL NEEDLE APPEARED SHORTER THAN WHEN INITIALLY PLACED" AND THE NEEDLE "APPEARED ALTERED UPON REMOVAL OF THE SPINAL NEEDLE." DOCTOR CONTINUED THE PROCEDURE BY ADMINISTERING THE EPIDURAL WITH A 17G TUOHY NEEDLE WHILE THE TIP OF THE SPINAL NEEDLE REMAINED EMBEDDED IN THE PATIENT'S LUMBAR SPINE. AFTER DELIVERY, PATIENT WAS TRANSFERRED TO PACU TO BE EVALUATED FOR REMOVAL OF THE "SPINAL CATHETER TIP." PATIENT UNDERWENT AN X-RAY AND CT OF LUMBAR SPINE. THE ASSESSMENT OF PATIENT'S SPINE SHOWED THAT THERE IS A 2.4 CM NEEDLE FRAGMENT SUPERFICIAL TO THE RIGHT LAMINA OF L3. THE NEEDLE TIP IS LOCATED AT LAMINA AND EXTENDS ALONG THE POSTERIOR SPINOUS PROCESS. IT DOES NOT ENTER THE SPINAL CANAL. THERE ARE BUBBLES IN THE PARASPINOUS AREA AT L4. TH

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 18363765 ↗
• InjuryDec 4, 2023

  DESCRIBE EVENT, PROBLEM, OR PRODUCT USE ERROR: PT WAS ADMINISTERED SPINAL BUPIVACAINE 0.75% (1.5 ML) AND SPINAL MORPHINE 200 MCG AT 7:30 AM PRIOR TO CESAREAN SECTION AT L3-L4. PER ANESTHESIA NOTES, SHE REPORTED SOME NUMBNESS, BUT STILL COULD MOVE LEGS AND HAD EXTREME PAIN WHEN TESTED. SHE REQUIRED CONVERSION TO GENERAL ANESTHESIA. THE BUPIVACAINE IS PART OF A PENCAN SPINAL NEEDLE KIT MADE BY B BRAUN.

  Patient problems: Inadequate Pain Relief; Numbness

  MAUDE report 18266545 ↗
• InjuryNov 30, 2023

  PT HAD SUBTHERAPEUTIC RESPONSE TO SPINAL ADMINISTRATION OF BUPIVACAINE DURING CESAREAN SECTION. PER ANESTHESIOLOGIST, THE PT FELT THE "COLD" PREP, WHICH IS UNUSUAL. SPINALS TYPICALLY SET UP QUICK AND THE PT'S SENSE OF TEMPERATURE IS THE FIRST SENSATION TO BE LOST. THE PT ALSO VOICED THAT SHE FELT MORE PAIN ON THE RIGHT SIDE PRIOR TO INCISION DURING TESTING. THE PT DECLINED THE OPTION TO HAVE GENERAL ANESTHESIA; WAS ABLE TO MAINTAIN COMFORT WITH SUPPLEMENTAL 200 MCG OF IV FENTANYL IN 50 MCG INCREMENTS. THIS IS THE SECOND CASE THIS DAY WITH SUBTHERAPEUTIC RESPONSE. REF REPORT: MW5148621.

  Patient problems: Alteration in Body Temperature; Pain

  MAUDE report 18245948 ↗
• MalfunctionSep 21, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: DURING ANESTHESIA INDUCTION, SPINAL NEEDLE BROKE OFF WHILE MD WAS REMOVING THE NEEDLE FROM THE SITE. NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17791225 ↗
• MalfunctionSep 21, 2023Break; Break

  ADDITIONAL INFORMATION PROVIDED: PATIENT ENDED UP RECEIVING A CT AND SURGERY WAS DONE TO REMOVE THE NEEDLE. PATIENT IS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17790998 ↗
• MalfunctionJul 14, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE USER FACILITY: REPORTED ADES: FAILED SPINAL, POST DURAL PUNCTURE HEADACHE (PDPH) (HAD TO PLACE 2 SPINALS FOR A CESAREAN SECTION) ON (B)(6) 2023 NO HARM CAME TO THE PATIENT, BUT I DID ALSO RECENTLY PLACE A BLOOD PATCH FOR A PATIENT WHO DR ARTHUR ALSO HAD TO PLACE 2 SPINALS FOR CESAREAN DELIVERY. (SHE ENDED UP WITH PDPH) I WAS MAINLY CONCERNED THAT SECOND SPINAL DOSE WOULD RESULT IN A HIGH SPINAL.

  Patient problems: Cerebrospinal Fluid Leakage; Headache; Needle Stick/Puncture

  MAUDE report 17325002 ↗
• MalfunctionApr 17, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAIL: NEEDLE BROKE OFF DURING SPINAL PROCEDURE FOR C SECTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16755824 ↗
• InjuryMar 13, 2023Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: SPINAL NEEDLE BROKE IN PATIENT'S BACK. AS REPORTED BY THE CUSTOMER, "NO INJURY; MEDICAL INTERVENTION NECESSARY; TYPE OF INTERVENTION: NEEDLE REMOVAL, DO NOT HAVE DETAILS"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531623 ↗
• MalfunctionDec 9, 2022Therapeutic or Diagnostic Output Failure

  OUR SEASONED ANESTHESIA TEAM REPORTS 3 RECENT FAILED SPINAL ANESTHESIA ENCOUNTERS WHEN USING BRAUN'S BUPIVACAINE 0.75% (NDC 0264-9379-88, ONE SUCH LOT IS 20328A THAT EXP 3/2025) TAKEN OUT OF A BRAUN PRE-PACKAGED PENCAN (R) SPINAL NEEDLE TRAY LABELED AS GTIN (B)(4), EXP 4-30-2024, LOT 0061850656. THEY REPORT HOSPIRA'S 0.75% (NDC 0409-3613-01) VIAL HAS NO EFFICACY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15959001 ↗
• MalfunctionNov 21, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE NEEDLE BROKE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833468 ↗
• InjuryJun 16, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: "ANESTHESIOLOGIST WAS USING THE NEEDLE IN ONE OF B. BRAUN'S P25BK PACKS, AND IT SNAPPED OFF MID NEEDLE IN THE PATIENTS SPINE. THANKFULLY OUR SPINE SURGEON WAS WORKING IN THE CLINIC THAT DAY, SO HE CAME OVER AND REMOVED IT WITHOUT ANY COMPLICATIONS. THE PATIENT IS DOING JUST FINE"

  Patient problems: Foreign Body In Patient

  MAUDE report 14711905 ↗
• MalfunctionApr 20, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: A PHYSICIAN WAS PREPARING TO ADMINISTER A SPINAL TO A PATIENT. WHEN HE LOOSENED THE NEEDLE FROM THE STYLET HE NOTICED SOMETHING BLACK MOVE INSIDE THE CHAMBER. WHEN HE DUMPED OUT THE CHAMBER ONTO THE PAPER OF THE KIT HE FOUND A TINY GNAT. "ADDITIONAL INFO FROM THE CUSTOMER: IT WAS NOT ALIVE. I BELIEVE THE MOVEMENT WAS A RESULT OF THE DEAD BUG JARRED BY REMOVAL OF THE SPINAL NEED STYLET". NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161608 ↗
• MalfunctionFeb 21, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION THE PATIENT WAS RECEIVING A SPINAL AND THE NEEDLE BROKE OFF OF THE HUB. NOW THE SPINAL NEEDLE IS FULLY SUBMERGED INTO THE PATIENT'S BACK & THEY WILL BE GOING INTO SURGERY TO REMOVE THE NEEDLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13567495 ↗