MEDRAD SWABBABLE VALVE TRANSFER SET
Received Mar 22, 2017 · Event occurred Feb 24, 2017
Report 2520313-2017-00018 · MDR key 6424985
Device
Generic name
Tubing, Fluid Delivery
Manufacturer
Bayer Medical CareModel number
60729202Catalog number
SVTS
Lot number
UNKNOWN
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED PRODUCT. VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMED THE PRESENCE OF PARTICULATE INSIDE THE TUBING. EXAMINATION OF THE PARTICULATE FOUND IT TO BE PARTIALLY EMBEDDED WITHIN THE TUBING WALL. THE PARTICULATE MEASURES APPROXIMATELY 1.25 CM IN LENGTH. OUR INVESTIGATION DETERMINED THAT THE PARTICULATE NOTED IN THE SYRINGE WAS INTRODUCED DURING THE MANUFACTURING PROCESS. THE SYRINGE KIT INSTRUCTIONS FOR USE INSTRUCTS THE USER TO "VISUALLY INSPECT CONTENTS AND PACKAGE BEFORE EACH USE". THIS VISUAL INSPECTION IS TO ENSURE PARTICULATES ARE NOTICED AND MITIGATED, WHICH IS WHAT OCCURRED IN THIS REPORTED INSTANCE.
Description of Event or Problem
THE FOLLOWING INFORMATION WAS OBTAINED FROM THE CUSTOMER: THE CUSTOMER REPORTED BLACK FOREIGN BODY INSIDE THE TRANSFER SET TUBING. NO INJURY OR ADVERSE EVENT WAS REPORTED.