REMOVE WIPES CTN 50
Received May 5, 2022 · Event occurred Apr 14, 2022
Report 8043484-2022-00144 · MDR key 14290907
Device
Generic name
Solvent, Adhesive Tape
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
59403125
Lot number
5962
Product problems
- Delivered as Unsterile Product
- Device Emits Odor
- Device Damaged Prior to Use
- Tear, Rip or Hole in Device Packaging
- Unexpected Color
- Delivered as Unsterile Product
- Device Emits Odor
- Device Damaged Prior to Use
- Tear, Rip or Hole in Device Packaging
- Unexpected Color
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, 15 BOXES OF REMOVE WIPES WERE NOTICED TO BE DISCOLORED, DAMP AND EMITTING AN UNEXPECTED ODOR WHEN UNPACKAGED. THEY APPEAR LEAKY AND MOIST .NO PATIENT WAS INVOLVED WHEN NOTICING THESE CONDITIONS ON THE BOXES.
Description of Event or Problem
IT WAS REPORTED THAT WHILE UNPACKAGING REMOVE WIPES DURING INSPECTION, THERE WAS DISCOLORATION ON THE BOXES AND FOIL POUCHES. THE PACKAGES WERE LEAKY AND DAMP AND EMITTED A STRONG ODOR. A TOTAL OF 15 BOXES OF WIPES WERE AFFECTED. PHOTOS PROVIDED CONFIRM A SINGLE POUCH CONTAINED WITHIN ONE OF THE BOXES IS DAMAGED (RIPPED/TORN).
Additional Manufacturer Narrative
H6 REASSESSMENT OF THIS INCIDENT FOUND IT NOT TO FULFILL REPORTING CRITERIA. THIS EVENT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY AND IS CONSIDERED NOT REPORTABLE PURSUANT TO 21 CFR §803.