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PENCAN® 333858Recalls & reported problems

B. Braun Medical Inc. · Pencan® 25 Ga. x 3-1/2 in. (90 mm) Tray (Kit) · 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 04046964180705), received between Aug 16, 2018 and Aug 16, 2018 — 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.

Most reported problems

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 16, 2018Break; Break

    AS REPORTED BY THE USER FACILITY: PROBLEM: END USER STATES THAT DURING A PROCEDURE THE PATIENT (MALE) RECEIVED AN UNEVENTFUL/UNCOMPLICATED SPINAL AND DURING INSERTION THE NEEDLE BROKE OFF. AN ATTEMPT WAS MADE TO EXCISE THE BROKEN PIECE WITHOUT SUCCESS. PATIENT WAS SCANNED AND IT WAS CONFIRMED THE PATIENT HAD RETAINED THE PIECE IN SOFT TISSUE. THE PATIENT DID NOT HAVE ANY AFFECTS. PATIENT WAS REFERRED TO NEUROSURGEON FOR FOLLOW UP CUSTOMER TO CONFIRM IF THE PATIENT HAD SURGERY DELAYED OR NOT. IT WAS CONFIRM THAT THE PATIENTS PROCEDURE WAS ABORTED DUE TO THE DEFECT. THE PATIENT WAS ASYMPTOMATIC; HOWEVER WAS REFERRED TO NEUROSURGERY.

    Patient problems: Foreign Body In Patient

    MAUDE report 7791876 ↗

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