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

Model Number PNM-S100NCV

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  

Manufacturer Narrative

Neomed requested follow up information from the user facility on (b)(6) 2019.The first response from the user facility was on (b)(6) 2019.The user facility noted in the response on (b)(6) 2019 that "we usually use the 100ml syringes to deliver feeds directly into the ng tube, not via a drip method." on (b)(6) 2019, the complainant reviewed product brochures for the neomed gravitypro and followed up via email indicating that "maybe we misunderstood the intent of these 100ml syringes" and "maybe there was no trouble with the syringes after all!" additional education sessions were offered to the nurse manager and team.It was confirmed by neomed quality that the current product instructions for use provides information regarding the vent zone and that improper syringe selection or syringe profile from a pump menu when using a pump may lead to inadequate delivery.The ifu also mentions that moving the plunger into the vent zone prior to the attachment of feeding tube or extension set may lead to leakage or inadequate delivery.The complaint device was returned from the user facility and received by neomed on (b)(6) 2019.A visual inspection of the sample was performed by neomed quality associate on (b)(6) 2019.No visual defects were noted upon evaluation that would contribute to the event as reported.An additional functionality review of the complaint device is pending.

Event Description

Baby with g-tube restarting feeds via gravity/drip method.Baby has order to feed "neocate, 22ml/hr to gravity." 70ml of milk was drawn up in 100ml neomed enfit syringe, connected to an abc infant enteral feeding pump, set to infuse at 22ml/hr.When rn looked at syring 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 the 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.

Manufacturer Narrative

The complaint device was decontaminated on 11 october 2019.Functionality review of the complaint device was performed by neomed engineering and quality on 13 november 2019.It was noted that a crack was present where the tip meets the syringe barrel.The crack allowed air into the syringe barrel (presence of visual air bubbles) resulting in fluid to leave faster than the prescribed rate.

• 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: 8995174
• MDR Text Key: 208760355
• Report Number: 3006520777-2019-00007
• Device Sequence Number: 1
• Product Code: PNR
• UDI-Device Identifier: 10817584012162
• UDI-Public: 0110817584012162172007191020170720
• Combination Product (y/n): N
• PMA/PMN Number: K161039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/29/2019,09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2020
• Device Model Number: PNM-S100NCV
• Device Catalogue Number: PNM-S100NCV
• Device Lot Number: 20170720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• 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
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 MO