MAUDE Adverse Event Report: AMSINO INTERNATIONAL INC. SYRINGE, FEEDING ENFI 60ML; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Lot Number 178216KS

Patient Problem Insufficient Information (4580)

Event Date 03/09/2023

Event Type  Injury  

Event Description

"(b)(4)": product quality issue - possible defect.Pt called about the feeding syringe he got at the beginning of this month.Said they were a new brand this time and they are flimsy and breaking when he uses them.

• Brand Name: SYRINGE, FEEDING ENFI 60ML
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): AMSINO INTERNATIONAL INC.; 708 corporate center drive; pomona CA 91768
• MDR Report Key: 18093497
• MDR Text Key: 327716313
• Report Number: MW5147899
• Device Sequence Number: 1
• Product Code: PNR
• UDI-Device Identifier: 10704411007
• UDI-Public: 10704411007
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 178216KS
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male