MalfunctionPEZ
CVC DRESSING KIT TEGADERM
Received Mar 9, 2021 · Event occurred Feb 5, 2021
Report 11445299 · MDR key 11445299
Device
Generic name
Central Venous Catheter Dressing Change Kit
Manufacturer
Medical Action Industries Inc.Model number
58193Catalog number
58193
Lot number
279271
Product problems
- Component Misassembled
- Material Split, Cut or Torn
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
WHILE COMPLETING A DRESSING CHANGE ON A PATIENT A DEFECT WITH THE TEGADERM W//CHG WAS DISCOVERED ON THE KIT WITH LOT #279271. THE RN NOTICED SEVERAL CUTS AROUND THE EDGES OF DRESSING AND AFTER PEELING THE BACK PAPER TO APPLY TO PATIENT, THE STICKY SIDE WAS FACED UPWARD. WE LOOK AT ALL DRESSING IN BOTH SUPPLY ROOMS THIS WAS THE ONLY KIT WITH LOT # 279271. MOST ALL OTHERS WERE LOT #275593 AND THESE DRESSINGS APPEAR TO BE FINE.