Bone Marrow Biopsy Needle, RBN-84 8 Gauge x 4"Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858690006983), received between Nov 10, 2021 and Jan 4, 2022 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJan 4, 2022Break; Entrapment of Device; Difficult to Remove

  THE HANDLE ON THE JAMSHIDI NEEDLE BROKE WHILE OBTAINING CORE BIOPSY AND JAMSHIDI NEEDLE WAS UNABLE TO BE REMOVED. NP CONTACTED MD, WHO WAS UNABLE TO REMOVE THE NEEDLE. ORTHOPEDIC SURGERY WAS CONSULTED AND ABLE TO REMOVE THE NEEDLE. TIP WAS INTACT UPON REMOVAL. PATIENT FOLLOWED UP WITH PELVIC XR TO ENSURE NO REMAINING NEEDLE OR NEEDLE FRAGMENTS IN HIP/PELVIS.

  Patient problems: Foreign Body In Patient

  MAUDE report 13151371 ↗
• MalfunctionNov 10, 2021Break

  DURING THE PATIENT'S BONE MARROW BIOPSY PROCEDURE, THE CORE NEEDLE WAS INSERTED INTO THE BONE AND DURING REMOVAL OF THE NEEDLE THE DEVICE BROKE AT THE PLASTIC ATTACHMENT TO THE METAL CORE NEEDLE. SEVERAL ATTEMPTS WERE MADE TO REMOVE IT, AND ULTIMATELY AN ORTHO CONSULT WAS CALLED. LEVEL 1 PELVIC XRAY PA AND LATERAL WERE OBTAINED TO ASSESS POSITIONING. ORTHO WAS ABLE TO REMOVE THE NEEDLE USING STERILE PLIERS. POST-REMOVAL X-RAYS WERE OBTAINED TO ENSURE NO FOREIGN BODIES WERE LEFT IN THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 12786523 ↗