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

Model Number	PFTM8.0P-EO
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	03/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is in response to medwatch user facility report # (b)(4).
Event or Problem Description
Gastric perforation was identified in a sextuplet nicu patient (patient identifier: (b)(6)) after signs and symptoms of abdominal distention.Gastric perforation was identified and corrected in surgery.

• Brand Name: NEOMED ENTERAL FEEDING TUBE
• Common Device Name: TUBE, FEEDING
• Manufacturer (Section D): NEOMED, INC; 100 londonderry court; suite 112; woodstock GA 30188
• MDR Report Key: 8514522
• Report Number: 3006520777-2019-00004
• Device Sequence Number: 16740253
• Product Code: FPD
• UDI-Device Identifier: 00817584012837
• UDI-Public: (01)00817584012837(17)210824(10)20180825
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2021
• Device Model Number: PFTM8.0P-EO
• Device Catalogue Number: PFTM8.0P-EO
• Device Lot Number: 20180825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 04/15/2019
• 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: Required Intervention
• Patient Age: 1 DA
• Patient Weight: 1