InjuryKMK
STATLOCK
Received Jul 9, 2026
Report MW5190494 · MDR key 25761696
Device
Generic name
Device, Intravascular Catheter Securement
Manufacturer
UnknownPatient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
ACCORDING TO THE REPORTER, WHEN A STATLOCK DEVICE WAS USED, IT WAS OBSERVED THAT BLOOD WAS LEAKING FROM THE EXTENSION LINE. THE CUSTOMER SUSPECTS THAT THE STATLOCK DEVICE MAY HAVE POTENTIALLY DAMAGED THE CATHETER SURFACE. THERE WAS NO REPORTED PATIENT OUTCOME. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).