MEDLINE
Received Apr 16, 2026 · Event occurred Mar 30, 2026
Report 3004519921-2026-00014 · MDR key 24900270
Device
Generic name
Dressing Change Kit Large
Manufacturer
Tri-state De Mexico, S. De R.l. De C.vCatalog number
EBSI1082A
Lot number
2025050990
Product problems
- Loss of or Failure to Bond
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED ON 04/04 THAT A DRESSING PLACED OVER THE CENTRAL LINE LIFTED OFF THE SKIN SHORTLY AFTER APPLICATION. DUE TO LOSS OF ADHESION, THE CENTRAL LINE SITE REQUIRED RE-CLEANING AND PLACEMENT OF A NEW STERILE DRESSING. THE INITIAL DRESSING WAS DISCARDED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED ON 04/04 THAT A DRESSING PLACED OVER THE CENTRAL LINE LIFTED OFF THE SKIN SHORTLY AFTER APPLICATION. DUE TO LOSS OF ADHESION, THE CENTRAL LINE SITE REQUIRED RE-CLEANING AND PLACEMENT OF A NEW STERILE DRESSING. THE INITIAL DRESSING WAS DISCARDED.