KATETERVEN.CV.MONT. SL.1-5-100
Received Oct 30, 2015
Report 3005778470-2015-31073 · MDR key 5190173
Device
Generic name
Connector, Catheter
Manufacturer
Unomedical S.r.o.Model number
90 805 1S - 10Catalog number
401985
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).
Description of Event or Problem
COMPLAINANT REPORTS "THE VALVE IS LEAKING WHEN IT HAS BEEN OPENED AND CLOSED A FEW TIMES (BETWEEN 5 AND 10 TIMES). THE ISSUE IS ALSO RELATED TO THE LEG BAG PRODUCT WITH THE SAME VALVE."