MAUDE Adverse Event Report: BIOVENTUS LLC. DUROLANE PREFILLED SYRINGE; ACID, HYALURONIC, INTRAARTICULAR

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2023

Event Type  malfunction  

Event Description

Provider went to inject durolane injection and the needle popped off and medication went everywhere.

• Brand Name: DUROLANE PREFILLED SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 16121848
• MDR Text Key: 306997730
• Report Number: MW5114218
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 01/05/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2023
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female