SIMILAC INFANT NIPPLE & RING
Received Jul 26, 2018 · Event occurred Jul 14, 2018
Report 7721917 · MDR key 7721917
Device
Product problems
- Material Deformation
Patient
11 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
RN WHO WAS FEEDING BABY NOTICED THAT HE TOOK HIS PO VOLUME FASTER THAN THE PREVIOUS CARE TIMES. AFTER 30 MLS HAD BEEN NIPPLED, RN REMOVED THE NIPPLE FROM THE BABY'S MOUTH TO BURP AT WHICH TIME SHE NOTICED THE NIPPLE WAS MISSING A CHUNK OUT OF THE SIDE OF IT. THE BABY DID NOT CHOKE OR DESAT WHILE EATING. THE MISSING PIECE OF THE NIPPLE WAS UNABLE TO BE FOUND. PHOTOGRAPH ATTACHED TO THIS REPORT. ====================== MANUFACTURER RESPONSE FOR INFANT NIPPLE AND RING, SIMILAC INFANT NIPPLE & RING (PER SITE REPORTER). ====================== SPOKE TO MANUFACTURER WHO ADVISES THAT THEY WILL BE SENDING A BOX TO SEND THE DEVICE BACK IN. THEY DID ASK THAT I ALSO SEND AN UNOPENED DEVICE ALONG WITH THE DEFECTIVE DEVICE BACK FOR LABORATORY COMPARISON.