MalfunctionNAB
CUSTOM RETROGRADE KIT
Received May 24, 2017 · Event occurred May 18, 2017
Report 6587066 · MDR key 6587066
Device
Generic name
Gauze, General Surgery (retrograde Kit)
Manufacturer
Medline Industries Inc.Model number
KENDALL 4X4 GAUZE, VENDOR ITEM 2733Catalog number
DYNJ47873B
Lot number
171B0499
Product problems
- Device Contamination With Biological Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DURING SET-UP FOR USE IN A PROCEDURE, THE TECHNOLOGIST FOUND A HAIR IN THE KIT. THE HAIR WAS ISOLATED AND SAVED. THIS WAS FOUND IN THE RETROGRADE PACK REF: (B)(4) CUSTOM KIT; LOT 171B0499. WE ARE FOLLOWING UP WITH OUR MEDLINE REPRESENTATIVE REGARDING ONGOING QUALITY CONCERNS.