MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 1% SODIUM HYALURONATE; ACID, HYALURONIC, INTRAARTICULAR

Model Number 4100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2022

Event Type  malfunction  

Event Description

Provider was injecting the patient and went to 'aspirate' the injection to check for blood in the syringe, and the plunger came out of the syringe while still in the patient.Provider said the plunger should be screwed into the medication and it was not.

• Brand Name: EUFLEXXA 1% SODIUM HYALURONATE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.; 100 interpace pkwy; parsippany NJ 07054
• MDR Report Key: 13414755
• MDR Text Key: 284823072
• Report Number: 13414755
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4100
• Device Lot Number: 029144
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/28/2022
• Date Report to Manufacturer: 02/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1