MalfunctionGCD
KATETERVEN.CV.MONT. SL.1-5-100
Received Oct 29, 2015
Report 3005778470-2015-31062 · MDR key 5188055
Device
Generic name
Connector, Catheter
Manufacturer
Unomedical S.r.o.Model number
90 805 1S - 10Lot number
409200
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A). EVALUATION CONCLUSIONS ARE REFLECTED.
Description of Event or Problem
COMPLAINANT REPORTS "2 OF 10 VALVE LEAKED, MAINLY ON THE WHITE SIDE WHEN IT WAS CLOSED, SOMETIME AT THE BOTTOM."