MAUDE Adverse Event Report: NEOMED, INC. NEOCONNECT GRAVITYPRO; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Lot Number 20170720

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 07/22/2019

Event Type  malfunction  

Event Description

Baby with g-tube restarting feeds via gravity/drip method.Baby has order to feed "neocate, 22 ml/hr to gravity." 70 ml of milk was drawn up in 100ml neomed enfit syringe, connected to an abc infant enteral feeding pump, set to infuse at 22 ml/hr.When rn looked at syringe an hour or so later, the syringe no longer had milk in it, even though the pump was going as expected and plunger was in place in syringe.Feeding infused too quickly, possibly due to some sort of "leak" in system, allowing milk to go in via gravity rather than the prescribed rate.Rn tested the same syringe/pump with water after this event, and same results occurred.Syringe of milk emptied prior to expected time via pump.Same rn tested a 2nd 100ml syringe to see if the same thing would happen, and it infused as expected.

• Brand Name: NEOCONNECT GRAVITYPRO
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): NEOMED, INC.; 100 londonderry court; suite #112; woodstock GA 30188
• MDR Report Key: 8864048
• MDR Text Key: 153368022
• Report Number: 8864048
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 20170720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 120 DA
• Patient Weight: 7