Jamshidi BEK3411Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403057250), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Aug 24, 2021Terminated

   Due to misbranded products shipped to customers.

   Z-0154-2022 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 12, 2019Defective Component

  DEFECTIVE JAMSHIDI BONE MARROW BIOPSY/ASPIRATION NEEDLE WOULD NOT DRAW AS VACUUM COULD NOT BE ESTABLISHED. THIS CAUSED THE PATIENT SIGNIFICANT PAIN IN SEVERAL UNSUCCESSFUL ATTEMPTS TO ASPIRATE. NEW KIT OPENED AND JAMSHIDI WORKED NORMALLY. A TINY LEAK WAS DEMONSTRATED AT THE HUB OF THE DEFECTIVE JAMSHIDI. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Pain

  MAUDE report 9467050 ↗