FOLYSIL SILICONE CATHETER 16FR
Received Apr 4, 2008 · Event occurred Jan 16, 2008
Report 9610711-2008-00002 · MDR key 1025351
Device
Generic name
Silicone Foley Catheter
Manufacturer
Coloplast Manufacturing France, SasModel number
AA6118Catalog number
AA6118
Lot number
06110102
Product problems
- Detachment Of Device Component
- Tip breakage
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
ACCORDING TO THE INFO RECEIVED, DURING USE OF A STYLET, THE TIP OF THE CATHETER DISCONNECTED FROM THE CATHETER. THIS WAS OBSERVED PRIOR TO USE, SO THERE WAS NO CLINICAL CONSEQUENCE.
Additional Manufacturer Narrative
ADD'L INFO HAS BEEN REQUESTED. AT THIS TIME, NO RESPONSE HAS BEEN RECEIVED. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD THE DEVICE OR ADD'L INFO BE RECEIVED, AN ADDENDUM TO THIS REPORT WILL BE FILED. UPON REVIEW OF THE LOT HISTORY RECORDS, NO DEFECTS WERE NOTED DURING GLUING OF THE TIP. NO ADD'L REPORTS HAVE BEEN RECEIVED FOR THIS LOT.