MalfunctionFMI
KENDALL MONOJECT MAGELLAN SAFETY BLOOD COLLECTORS
Received Jan 9, 2011
Report MW5018931 · MDR key 1959759
Device
Generic name
Phlebotomy Needle To Draw Blood
Manufacturer
Tyco Healthcare Group LpModel number
KENDALL SAFETYCatalog number
8881227121
Lot number
020900428
Product problems
- Break
- Device Contamination with Chemical or Other Material
- Material Deformation
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
PROBLEM WITH A MEDICAL DEVICE: PHLEBOTOMY BLOOD DRAW NEEDLE, COVER OF NEEDLE IS MELTED OR DAMAGED BY WHAT APPEARS TO BE HEATED TO THE MELTING POINT, NEEDLE SHAFT HAS PARTICLES ALONG THE NEEDLE SHAFT, PROBABLE PLASTIC FROM THE NEEDLE COVER.