MalfunctionNAB
RETROGRADE KIT
Received May 24, 2017 · Event occurred May 14, 2017
Report 6587361 · MDR key 6587361
Device
Generic name
Gauze, General Surgery (retrograde Pack)
Manufacturer
Medline Industries Inc.Model number
KENDALL 4X4 GAUZE, VENDOR ITEM 2733Catalog number
DYNJ47873B
Lot number
171B0499
Product problems
- Material Fragmentation
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 GAUZE 4X4S WERE OBSERVED TO BE LOSING SMALL SHREDS OR FLAKES OFF EDGES. THIS IS THE SECOND EVENT OF "FLAKING GAUZE" THAT WAS REPORTED FOR RETROGRADE PACK REF: (B)(4) (CUSTOM KIT); LOT 171B0499. THE 4X4 GAUZE IS A PRODUCT OF KENDALL HEALTHCARE, VENDOR ITEM (B)(4).