MAUDE Adverse Event Report: NEOMED, INC. NEOCONNECT ENTERAL FEEDING TUBE; TUBE, NASOGASTRIC

Model Number	PFTL5.0P-NC
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Ng tube for infant with screw in end-piece.With this device the cap is secured to the feeding tube by its loop but can freely migrate up and down length of tube when opened for period of time in which feeding is administered by feeding pump.Infant was noted to have moved his head during feeding and screw cap migrated down length of tube and put pressure on infant's face.Small indentation noted on face at end of feeding when syringe was detached and rn sought screw cap end to close off end of feeding tube.Concern over pressure ulcer potential or choking hazard due to freely movable piece.

• Brand Name: NEOCONNECT ENTERAL FEEDING TUBE
• Common Device Name: TUBE, NASOGASTRIC
• Manufacturer (Section D): NEOMED, INC.; 100 londonberry ct, suite 112; woodstock GA 30188
• MDR Report Key: 9928225
• Report Number: 9928225
• Device Sequence Number: 2238508
• Product Code: FPD
• UDI-Device Identifier: 00817584011748
• UDI-Public: (01)00817584011748
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/09/2020
• Report Date (Section F): 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: PFTL5.0P-NC
• Device Catalogue Number: PFTL5.0P-NC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 30 DA
• Patient Weight: 2
• Date Report Sent to FDA: 03/09/2020