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

Model Number PFTM8.0P-EO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 03/16/2019

Event Type  Injury  

Manufacturer Narrative

This report is in response to medwatch user facility report # (b)(4).

Event 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
• Type of Device: TUBE, FEEDING
• Manufacturer (Section D): NEOMED, INC; 100 londonderry court; suite 112; woodstock GA 30188
• Manufacturer (Section G): SYNECCO, CO., LTD.; b801 rongan plaza; no. 700 south tiantong road; ningbo, yinzhou district 31510 0; CH 315100
• Manufacturer Contact: melinda smith ; 100 londonderry court; suite 112; woodstock, GA 30188 ; 7704855188
• MDR Report Key: 8514521
• MDR Text Key: 141951328
• Report Number: 3006520777-2019-00003
• Device Sequence Number: 1
• Product Code: FPD
• UDI-Device Identifier: 00817584012837
• UDI-Public: (01)00817584012837(17)210824(10)20180825
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2019
• Initial Date FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 DA
• Patient Weight: 1