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

Model Number NM-S35EO

Device Problems Break (1069); Failure to Prime (1492)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2022

Event Type  malfunction  

Event 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.

• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 13710132
• MDR Text Key: 286855646
• Report Number: 13710132
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00350770002620
• UDI-Public: (01)00350770002620
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 02/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female