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

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2021

Event Type  malfunction  

Event 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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): NEOMED, INC. / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); 100 londonderry ct; woodstock GA 30188
• MDR Report Key: 13152611
• MDR Text Key: 283336515
• Report Number: MW5106437
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00817584011298
• UDI-Public: (01)00817584011298(17)231210(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Patient Sequence Number: 1