MalfunctionBZB
OXYGEN W/FOAM 08/040CM/74BL0O +
Received Nov 6, 2015
Report 3005778470-2015-31241 · MDR key 5208076
Device
Generic name
Catheter, Nasal, Oxygen
Manufacturer
Unomedical S.r.o.Model number
19039052Lot number
412678
Product problems
- Occlusion Within Device
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 OXYGEN CATHETER IS NOT PERMEABLE" (BLOCKED).