N/A
Received Apr 10, 2026
Report 3011610434-2026-00006 · MDR key 24839552
Device
Product problems
- Fluid/Blood Leak
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE DEVICE WAS REPORTED TO HAVE A HEMOSTATIC VALVE THAT WAS BACK FLOWING.
Additional Manufacturer Narrative
ON (B)(6) 2026, IT WAS REPORTED THAT THE HEMOSTATIC VALVE WAS BACK FLOWING. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE EVENT. UPON RECEIPT OF THE DEVICE FOR INVESTIGATION ON (B)(6) 2026, IT WAS NOTED DURING VISUAL INSPECTION THAT THERE WAS DAMAGE TO THE VALVE AS WELL AS THE HEMOSTASIS TUBING WAS PARTIALLY DETACHED FROM THE HUB. THE TUBING WAS ONLY PARTIALLY DETACHED FROM THE HUB AND REMAINED ATTACHED TO THE DEVICE. NO OTHER DAMAGE OR DEFECTS WERE NOTED ON THE RETURNED DEVICE. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED TO ENSURE THAT ALL MANUFACTURING AND INSPECTION PROCESS STEPS WERE PERFORMED AND NO ANOMALIES WERE NOTED. BASED ON THE VISUAL INSPECTION RESULTS, THE REPORTED ISSUE IS ABLE TO BE CONFIRMED. AS THE DEVICE MET ALL INSPECTION CRITERIA AT THE TIME OF MANUFACTURING, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.