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PENCAN® 333853Recalls & reported problems

B. Braun Medical Inc. · Pencan® 25 Ga. x 3-1/2 in. (90 mm) Spinal Needle · Class 2

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964180644), received between Dec 13, 2018 and May 20, 2019 — classified as 2 malfunctions.

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.

Most reported problems

Device problems

  • Break2

Patient problems

  • Device Embedded In Tissue or Plaque1
  • Foreign Body In Patient1

Recent adverse event reports

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

  • MalfunctionMay 20, 2019Break; Break

    AS REPORTED BY THE USER FACILITY: "'IN THE LABOR AND DELIVERY UNIT, A SPINAL NEEDLE "BROKE OFF" IN A PATIENT. THE PATIENT WILL BE GOING TO SURGERY TO HAVE THE BROKEN OFF PORTION REMOVED.'" NO FOLLOW-UP INFORMATION AVAILABLE AS OF 05/20/2019.

    Patient problems: Foreign Body In Patient

    MAUDE report 8624388 ↗
  • MalfunctionDec 13, 2018Break; Break

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY): NEEDLE TIP IS BROKEN OFF

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 8160545 ↗

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

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.