MalfunctionBZB

OXYGEN ADJFOAM 10/040CM/74BL8O +

Received Nov 9, 2015 · Event occurred Jun 24, 2011

Report 3005778470-2015-31237 · MDR key 5209924

Device

Generic name

Catheter, Nasal, Oxygen

Manufacturer

Unomedical S.r.o.

Model number

19030182

Lot number

401942

Product problems

Device Packaging Compromised

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. 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 "ANOMALY OF PACKAGING OXYGEN PROBES" (PRODUCT CAUGHT IN STERILE PACKAGE SEAL).