MAUDE Adverse Event Report: NEOMED, INC.; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

60 ml feeding syringe was found to be cracked/leaking feed.New syringe obtained.

• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): NEOMED, INC.; 100 londonderry ct, suite 112; woodstock GA 30188
• MDR Report Key: 10206648
• MDR Text Key: 196786887
• Report Number: 10206648
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2020
• Date Report to Manufacturer: 06/29/2020
• Type of Device Usage: N
• Patient Sequence Number: 1