MAUDE Adverse Event Report: ABBOTT NUTRITION ABBOTT LABORATORIES SIMILAC VOLU-FEED; NIPPLE, LAMBS FEEDING

Model Number 00180

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2017

Event Type  malfunction  

Event Description

Infant's feeding and medications prepared in disposable nurser/bottle.Upon inverting bottle to feed infant, small amount of formula and medications leaked out small crack in nurser/bottle.Contents of nurser/bottle were placed into new nurser/bottle and fed without further incident.Affected nurser/bottle and another unopened package that appeared to have same issue were saved for further investigation.

• Brand Name: SIMILAC VOLU-FEED
• Type of Device: NIPPLE, LAMBS FEEDING
• Manufacturer (Section D): ABBOTT NUTRITION ABBOTT LABORATORIES; 100 south saunders road; lake forest IL 60045
• MDR Report Key: 6686082
• MDR Text Key: 79066460
• Report Number: 6686082
• Device Sequence Number: 1
• Product Code: FNN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 00180
• Device Lot Number: 76081LS00 094 04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1