MAUDE Adverse Event Report: REGULAR SIMILAC NIPPLE

Lot Number 34162SG

Device Problems Air Leak (1008); No Flow (2991)

Patient Problem No Code Available (3191)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

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.

• Brand Name: REGULAR SIMILAC NIPPLE
• Type of Device: REGULAR SIMILAC NIPPLE
• MDR Report Key: 3636690
• MDR Text Key: 3985225
• Report Number: MW5034548
• Device Sequence Number: 1
• Product Code: FNN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2016
• Device Lot Number: 34162SG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 3 MO