PENCAN® 333875Recalls & reported problems
B. Braun Medical Inc. · Pencan® 25 Ga. x 5 in. (130 mm) Spinal Needle · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964180965), received between Dec 2, 2024 and Dec 2, 2024 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2024Break; Break
IT WAS REPORTED TO B. BRAUN MEDICAL INC. THAT A SPINAL NEEDLE (MATERIAL 333875, LOT 0061795871) WAS BEING USED TO ADMINISTER MEDICATION ON AN UNSPECIFIED DATE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, 25G SPINAL NEEDLE BROKE WHEN WITHDRAWN OUT OF THE INTRODUCER NEEDLE. INTRODUCER NEEDLE THEN WITHDRAWN, AND THE REST OF THE SPINAL NEEDLE CAME OUT WITH THE INTRODUCER. THE REST OF THE SPINAL NEEDLE WAS INTACT. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20817471 ↗
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- ARROW IPN923597Teleflex Incorporated · NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)1 recall0 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.