PENCANRecalls & reported problems across all models

We found 14 models of PENCAN by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 82 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2017 and Aug 19, 2026 — classified as 15 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Break” (67 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PENCAN recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. 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 · names 7 of these models · Recall details · FDA record ↗

Most reported PENCAN problems

PENCAN models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PENCAN® 333851

  Spinal anesthesia kit
  1 recall45 reports
• PENCAN® 333868

  Spinal anesthesia kit
  1 recall17 reports
• PENCAN® 333865

  Spinal anesthesia kit
  1 recall4 reports
• PENCAN® 333871

  Spinal anesthesia kit
  1 recall2 reports
• PENCAN® 333862

  Spinal anesthesia kit
  1 recall0 reports
• PENCAN® 333867

  Spinal anesthesia kit
  1 recall0 reports
• PENCAN® 560619

  Spinal anesthesia kit
  1 recall0 reports
• PENCAN® 332607

  Spinal anesthesia kit
  1 recall0 reports
• PENCAN® 333873

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  6 reports
• PENCAN® 333877

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  2 reports
• PENCAN® 333853

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  2 reports
• PENCAN® 333876

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  2 reports
• PENCAN® 333858

  Spinal anesthesia kit
  1 report
• PENCAN® 333875

  NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
  1 report

Recent PENCAN adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 16, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: INCIDENT_DESCRIPTION LORS DE L'ANESTHÉSIE RACHIDIENNE, IL Y A EU CONTACT OSSEUX AVEC L'AIGUILLE ET LORS DU RETRAIT POUR SE REPOSITIONNER, DÉCOUVERTE QUE L'AIGUILLE EST BRISÉE EN DEUX. LE BOUT DE L'AIGUILLE SPINALE A DÛ ÊTRE RETIRÉ CHIRURGICALEMENT. TRANSLATION: DURING THE SPINAL ANESTHESIA, THERE WAS BONE CONTACT WITH THE NEEDLE AND UPON WITHDRAWAL TO REPOSITION, IT WAS DISCOVERED THAT THE NEEDLE WAS BROKEN IN TWO. THE TIP OF THE SPINAL NEEDLE HAD TO BE SURGICALLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22039101 ↗
• 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 ↗
• 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 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 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls