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PENCAN® 333876Recalls & reported problems

B. Braun Medical Inc. · Pencan® 27 Ga. x 5 in. (127 mm) Spinal Needle · Class 2

All models of PENCAN (14)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964180989), received between Oct 1, 2024 and Dec 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break1
  • Deflation Problem1

Patient problems

  • Foreign Body In Patient2

Recent adverse event reports

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

  • InjuryDec 11, 2024Deflation Problem; Deflation Problem

    ACCORDING TO THE EVENT DESCRIPTION: DURING A CESAREAN SECTION USING SPINAL ANESTHESIA, AFTER SEVERAL ATTEMPTS, A DEFECT IN THE SPINAL NEEDLE WAS NOTICED (ABSENCE OF THE DISTAL END OF THE NEEDLE, ABOUT 4 CM LONG).

    Patient problems: Foreign Body In Patient

    MAUDE report 20907110 ↗
  • InjuryOct 1, 2024Break; Break

    ACCORDING TO THE CUSTOMER: "MALE PATIENT OF 44 YEARS OLD SCHEDULED BY THE SERVICE OF TRAUMATOLOGY AND ORTHOPEDICS FOR SURGICAL WASHING ON SEPTEMBER 3, DURING THE ANESTHETIC PROCEDURE WITH THE PATIENT IN POSITION SIMS AT THE MOMENT OF THE REMOVAL OF THE SPINAL NEEDLE WHITACRE 27 411/16 THIS COMES OUT INCOMPLETE, RADIOGRAPHY IS TAKEN AP AND LATERAL LUMBOSACRAL COLUMN, WHERE IMAGE OF THE REST OF THE NEEDLE IN THE YELLOW LIGAMENT BENT AT LEVEL L2-L3 IS OBSERVED. THIS HOSPITAL UNIT DOES NOT HAVE THE REQUIRED INFRASTRUCTURE THAT'S WHY THE PATIENT WAS SEND FOR THE NEXT LEVEL TO HAVE A PROMPT SURGICAL INTERVENTION. ATTACHED IMAGE OF THE NEEDLE IN QUESTION AND ANOTHER NORMAL AS REFERENCE. THEY ARE APPROXIMATELY 2 CENTIMETERS OF MISSING NEEDLE."

    Patient problems: Foreign Body In Patient

    MAUDE report 20345292 ↗

Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices

All NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices →

Sources and updates

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