REGULAR SIMILAC NIPPLE
Received Feb 11, 2014 · Event occurred Feb 7, 2014
Report MW5034548 · MDR key 3636690
Device
Generic name
Regular Similac Nipple
Lot number
34162SG
Product problems
- Air Leak
- No Flow
Patient
3 MO
- No Code Available
Narrative
Description of Event or Problem
INFANT BOTTLE FEEDING WITH REGULAR (B)(6) NIPPLE. THE FEEDING WAS NOT FLOWING OUT AND NO BUBBLES NOTED IN BOTTLE; NIPPLE CHANGED AND CHECKED, AND FEEDING DID FLOW OUT MANUALLY. AFTER 10 MINUTES, THE FEEDING STOPPED COMING OUT AND NO BUBBLES NOTED IN BOTTLE. NIPPLE CHANGED AGAIN WITH A NIPPLE FROM DIFFERENT BATCH NUMBER; AND MILK ABLE TO FLOW OUT, BUBBLES NOTED IN BOTTLE, AND INFANT FINISHED FEEDING IN LESS THAN 10 MINUTES. OTHER NIPPLES CHECKED MANUALLY FROM SAME BATCH, AND SAME THING HAPPENED; THE LIQUID WOULD START TO FLOW BUT THEN STOP. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.