inforMED
MalfunctionKNW

BONE MARROW BIOPSY NEEDLE, RBN-133

Received Jan 24, 2023 · Event occurred Jan 6, 2023

Report 16232756 · MDR key 16232756

Device

Generic name

Instrument, Biopsy

Manufacturer

Ranfac Corp.

Model number

74050-03M

Catalog number

RBN-133

Product problems

  • Obstruction of Flow
  • Activation, Positioning or Separation Problem
  • Material Twisted/Bent

Patient

2555 DA · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

BONE MARROW BIOPSY NEEDLE WAS UTILIZED; PROVIDER WAS ABLE TO OBTAIN BONE MARROW ASPIRATE BUT BIOPSY WAS NOT ABLE TO BE REMOVED FROM THE NEEDLE DEVICE. PROVIDER REPORTED WHAT APPEARS TO BE HAPPENING IS THAT THE TIP OF THE BIOPSY NEEDLE LIKELY IS BENT INWARD WHILE TRYING TO BORE THROUGH THE BONE MARROW, RESULTING IN DIFFICULTY OR INABILITY TO REMOVE THE BIOPSY.