MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) NEOMED ORAL/ENTERAL SYRINGE WITH ENFIT CONNECTOR; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Model Number PNM-S60NC

Device Problems Break (1069); Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

When connecting the 60 ml oral/enteral enfit connection syringe to the peg tube, a piece of the peg tube broke off in the enfit connector, preventing the cap to secure to the peg tube causing leaks.Fda safety report id # (b)(4).

• Brand Name: NEOMED ORAL/ENTERAL SYRINGE WITH ENFIT CONNECTOR
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 14829978
• MDR Text Key: 294933036
• Report Number: MW5110519
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PNM-S60NC
• Device Lot Number: TY210716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic