inforMED
MalfunctionKNW

RBN-133

Received Feb 21, 2023 · Event occurred Jan 16, 2023

Report 1211566-2023-00003 · MDR key 16408385

Device

Generic name

Bone Biopsy Needle 13 Gauge

Manufacturer

Ranfac Corp

Model number

74050-03M

Catalog number

74050-03M

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

Unknown

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

Narrative

Additional Manufacturer Narrative

DEVICE HAS NOT (YET) BEEN RETURNED FOR ANALYSIS. LOT DATA NOT PROVIDED.

Description of Event or Problem

THE SPECIMEN COULD NOT BE EXTRACTED FROM THE NEEDLE. BONE MARROW BIOPSY CORE STUCK IN NEEDLE AND UNABLE TO SEND SPECIMEN, HAD TO REPEAT BIOPSY.