MalfunctionBZB
OXYGEN W/FOAM 10/040CM/71DG0O +
Received Dec 11, 2015
Report 3005778470-2015-40057 · MDR key 5291115
Device
Generic name
Catheter, Nasal, Oxygen
Manufacturer
Unomedical S.r.o.Model number
19055339Lot number
463296
Product problems
- Kinked
- Packaging Problem
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) AND 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 "KINKS IN THE TUBE."