MAUDE Adverse Event Report: AVANOS MEDICAL, INC. NEOMED*; SYRINGE, PISTON

Model Number	NM-S35EO
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Rn primed feeding tube tubing and the tubing did not prime all the way through.This rn pulled back on the feeding tube syringe plunger to release the pressure to re-prime the tubing and top of the feeding tube syringe broke off.

• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 13710132
• Report Number: 13710132
• Device Sequence Number: 5333325
• Product Code: FMF
• UDI-Device Identifier: 00350770002620
• UDI-Public: (01)00350770002620
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2022
• Report Date (Section F): 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NM-S35EO
• Device Catalogue Number: NM-S35EO
• Device Lot Number: TY210726
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 02/28/2022