MAUDE Adverse Event Report: NEOMED, INC 0.5ML NEOCONNECT PHARMACY SYRINGE, NON-STERILE; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Device Problem Volume Accuracy Problem (1675)

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

Event Type  malfunction  

Manufacturer Narrative

Sus voluntary event report number mw5082682 stated this has caused adverse events, however, did not document the detail of any adverse events.To date, neomed has not be able to identify the reporting facility based on the information provided in report number mw5082682.We contacted facilities our "senior engineer" visited in q3 of 2018.All facilities contacted stated they did not file this sus voluntary event report.Neomed does not have any additional information pertaining to report number mw5082682.

Event Description

Complaint reported via sus voluntary event report number mw5082682.No initial reporter information provided.Report stated 0.5ml enfit syringes had been observed with a displacement of fluid syringe contents after placing the neomed syringe tip cap onto the syringe.

• Brand Name: 0.5ML NEOCONNECT PHARMACY SYRINGE, NON-STERILE
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): NEOMED, INC; 100 londonderry court; suite 112; woodstock, ga GA 30188
• Manufacturer (Section G): SYNECCO, CO., LTD.; b801 rongan plaza, no. 700; south tiantong road; yinzhou district, ningbo 31510 0; CH 315100
• Manufacturer Contact: melinda smith ; 100 londonderry court; suite 112; woodstock 30188 ; 7704855188
• MDR Report Key: 8374550
• MDR Text Key: 138253310
• Report Number: 3006520777-2019-00001
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• PMA/PMN Number: K161039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 12/28/2018,02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2018
• Event Location: Hospital
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1