MEDLINE
Received Mar 20, 2026 · Event occurred Feb 18, 2026
Report 1417592-2026-00236 · MDR key 24649725
Device
Generic name
Tray,irrigation,piston Syringe,60ml
Manufacturer
Medline Industries LpCatalog number
DYND20300
Product problems
- Decrease in Suction
- Infusion or Flow Problem
Patient
NA · Female
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT "SYRINGES DO NOT MAINTAIN AND ADEQUATE SEAL WHEN ATTEMPTING TO ASPIRATE BLOOD CLOTS THROUGH A FOLEY CATHETER". "ON THIS SPECIFIC PATIENT SHE WAS FOUND AT 1AM TO HAVE HER URINARY BLADDER COMPLETELY FILLED WITH BLOOD CLOTS". DUE TO THIS, A 3-WAY FOLEY CATHETER WAS INSERTED AND BEGAN CONTINUOUS BLADDER IRRIGATION. IT WAS REPORTED THAT EACH TIME NURSING STAFF HAS MANUALLY IRRIGATED THE FOLEY SINCE THE INITIAL INSERTION THEY HAVE NOT EXTRACTED ANY CLOTS. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY, THEREFORE, 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
SYRINGES DO NOT MAINTAIN AND ADEQUATE SEAL WHEN ATTEMPTING TO ASPIRATE BLOOD CLOTS THROUGH A FOLEY CATHETER.