MAUDE Adverse Event Report: NEOMED, INC. NEOCONNECT ORAL / ENTERAL SYRINGE; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Model Number NM-S35NC

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Date 11/15/2017

Event Type  malfunction  

Event Description

Nurse received 35 ml enteral feeding syringe from the infant formula room.Rn found sealing cap difficult to remove.While trying to twist cap from syringe barrel, the syringe connector snapped off of the syringe barrel.The nurse transferred the breast milk to another syringe and proceeded with the feeding.Damaged syringe removed and sent to biomedical for evaluation.Manufacturer response for enteral syringe, enfit compliant, neoconnect (per site reporter): awaiting response.

• Brand Name: NEOCONNECT ORAL / ENTERAL SYRINGE
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): NEOMED, INC.; 100 londonderry court suite 112; woodstock GA 30188
• MDR Report Key: 7120463
• MDR Text Key: 94957218
• Report Number: 7120463
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: NM-S35NC
• Device Catalogue Number: NM-S35NC
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1