MAUDE Adverse Event Report: FIDIA FARMACEUTICI SPA HYALGAN SODIUM HYLAURONATE PRE-FILLED SYRINGE - 2ML; ACID, HYALURONIC, INTRAARTICULAR

Model Number 72420

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 04/19/2019

Event Type  malfunction  

Event Description

Luer lock disconnected from syringe of prepackaged/prefilled hyalgan (sodium hyaluronate).

• Brand Name: HYALGAN SODIUM HYLAURONATE PRE-FILLED SYRINGE - 2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FIDIA FARMACEUTICI SPA; 100 campus drive, suite 105; florham park NJ 07932
• MDR Report Key: 8623347
• MDR Text Key: 145491718
• Report Number: 8623347
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72420
• Device Lot Number: B13550
• 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: 04/23/2019
• Event Location: Other
• Date Report to Manufacturer: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA