CENTURION
Received May 15, 2026
Report 3015173212-2026-00011 · MDR key 25194477
Device
Generic name
Dressing Change Tray
Catalog number
DT17560
Lot number
2025101090
Product problems
- Separation Problem
Patient
NA · Unknown
- Medical device site infection
Narrative
Description of Event or Problem
ACCORDING TO THE CUSTOMER, THE GLOVES ARE RIPPING AND "THE CL DRESSING INCLUDE IN OUR CURRENT KITS ARE NOT ADHERING WITH CORNERS LIFTING TO THE PATIENTS LEADING TO THE CL BEING EXPOSED. THEY ARE HAVING TO BE CHANGED EVERY 2-3 DAYS." THE FACILITY REPORTS THE CL SUTE EXPOSED IS BELIEVED THAT THIS WAS A CONTRIBUTING FACTOR TO CLABSI. THE PATIENT WAS TREATED FOR CLABSI. ON (B)(6) 2026, THE PATIENT HAD A POSITIVE BLOOD CULTURE. NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT.
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER, THE GLOVES ARE RIPPING AND "THE CL DRESSING INCLUDE IN OUR CURRENT KITS ARE NOT ADHERING WITH CORNERS LIFTING TO THE PATIENTS LEADING TO THE CL BEING EXPOSED. THEY ARE HAVING TO BE CHANGED EVERY 2-3 DAYS." THE FACILITY REPORTS THE CL SITE EXPOSED IS BELIEVED THAT THIS WAS A CONTRIBUTING FACTOR TO CLABSI. THE PATIENT WAS TREATED FOR CLABSI. ON (B)(6) 2026, THE PATIENT HAD A POSITIVE BLOOD CULTURE. NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.