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U.S. Department of Health and Human Services

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

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NEOMED, INC. / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) NEOMED 35ML ORAL SYRINGE FOR ORAL/ENTERAL USE SYRINGE, PISTON Back to Search Results
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).
 
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Brand NameNEOMED 35ML ORAL SYRINGE FOR ORAL/ENTERAL USE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
NEOMED, INC. / AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
100 londonderry ct
woodstock GA 30188
MDR Report Key13152611
MDR Text Key283336515
Report NumberMW5106437
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNM-S35EO
Device Catalogue NumberNM-S35EO
Device Lot NumberTY201211
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes

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