PENCAN® 333877Recalls & reported problems
B. Braun Medical Inc. · Pencan® 25 Ga. x 6.1 in. (156 mm) Spinal Needle · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046963069568), received between Jan 15, 2018 and May 16, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- Foreign Body In Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionJan 15, 2018Break; Break
AS REPORTED BY USER FACILITY: THE B. BRAUN SPINAL NEEDLE BROKE AT THE CONNECTION BETWEEN THE NEEDLE AND THE HUB. THE NEEDLE BREAK OCCURRED AS THE STYLET WAS BEING REMOVED FROM THE SPINAL NEEDLE WHICH WAS INSERTED IN THE EPIDURAL NEEDLE AS PART OF THE CSE TECHNIQUE. NO PATIENT INJURY, AS THIS OCCURRED DURING A DEMONSTATION.
Patient problems: No Patient Involvement
MAUDE report 7190083 ↗
Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices
- ARROW IPN922632Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)2 recalls0 reports
- ARROW IPN922603Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922605Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- 22G 1 1/2IN Regional Block Needle 408348Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922631Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- ARROW IPN922604Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
- BD QUINCKE Spinal Needles 405180Becton, Dickinson And Company · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)23 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.