MAUDE Adverse Event Report: NEOMED, INC. / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) NEOMED 35ML ORAL SYRINGE FOR ORAL/ENTERAL USE; SYRINGE, PISTON

Model Number	NM-S35EO
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Formula being prepared for patient's feeding as supplied.Cap to syringe breaking off in tip, unable to connect plunger and prime feeding.The formula then removed from syringe and placed into another syringe.Fda safety report id# (b)(4).

• Brand Name: NEOMED 35ML ORAL SYRINGE FOR ORAL/ENTERAL USE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): NEOMED, INC. / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); 100 londonderry ct; woodstock GA 30188
• MDR Report Key: 13152611
• Report Number: MW5106437
• Device Sequence Number: 20000301
• Product Code: FMF
• UDI-Device Identifier: 00817584011298
• UDI-Public: (01)00817584011298(17)231210(10)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 12/30/2021

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 Expiration Date: 12/10/2023
• Device Model Number: NM-S35EO
• Device Catalogue Number: NM-S35EO
• Device Lot Number: TY201211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown