RBN-114
Received Aug 22, 2023 · Event occurred Aug 1, 2023
Report 1211566-2023-00010 · MDR key 17594878
Device
Generic name
Snarecoil Bone Biopsy Needle 14 Gauge
Manufacturer
Ranfac CorpModel number
74050-01MCatalog number
74050-01M
Lot number
49088
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPON INVESTIGATION, IT WAS NOTED THAT THE DEVICE WAS ACTUALLY AN RBN-133. BASED ON THE NOTE PROVIDED BY UPMC, IT IS ASSUMED THAT THE PROVIDER MIXED UP THE DEVICES. THERE WAS NO SAMPLE LOCATED WITHIN THE DEVICE AND WAS BLOCKED BY CORTICAL BONE. THE CORTICAL BONE WAS VISIBLE FROM THE DISTAL END OF THE DEVICE. CORTICAL BONE ENTERED THE LUMEN, BLOCKING THE NEEDLE FROM BEING ABLE TO RETRIEVE THE SPECIMEN. THIS IS TYPICALLY CAUSED BY PREMATURE REMOVAL OF THE STYLET DURING THE PROCEDURE.
Description of Event or Problem
1. RANFAC SNARECOIL BONE MARROW BIOPSY NEEDLE WHILE USING BIOPSY SAMPLE STUCK IN NEEDLE UNABLE TO DISLODGE FOR TESTING. HAD TO ATTEMPT FOR ANOTHER SAMPLE USING A DIFFERENT NEEDLE.