MalfunctionGCD

KATETERVEN.CV.MONT.SL.1-25-100

Received Nov 5, 2015

Report 3005778470-2015-31201 · MDR key 5204242

Device

Generic name

Connector, Catheter

Manufacturer

Unomedical S.r.o.

Model number

90 804 1S-10

Product problems

Leak/Splash

Patient

Not reported

No Patient Involvement

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 21 CFR PART 803. 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

IT WAS REPORTED THAT THE VALVE LEAKS.