MAUDE Adverse Event Report: MEIJI PHARM SPAIN TRIVISC; ACID, HYALURONIC, INTRAARTICULAR

Device Problems Failure to Deliver (2338); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

Trivisc syringes are breaking during administration where hub and syringe attach.Needle is left in the patient and the syringe with drug is broken off resulting in incomplete administration of medication and patient requiring to be stuck again with a new syringe; 5 syringes over last 7 days.

• Brand Name: TRIVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): MEIJI PHARM SPAIN
• MDR Report Key: 14986873
• MDR Text Key: 295796008
• Report Number: MW5110799
• Device Sequence Number: 4
• Product Code: MOZ
• 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: 07/08/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1