MalfunctionBZB

OXYGEN 10/040CM/74GR8O +

Received Nov 6, 2015

Report 3005778470-2015-31234 · MDR key 5208016

Device

Generic name

Catheter, Nasal, Oxygen

Manufacturer

Unomedical S.r.o.

Model number

19006182

Lot number

392995

Product problems

Defective Device

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 21CFR 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

COMPLAINANT REPORTS THAT NO SIDE HOLES CAN BE FOUND.