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

Lot Number 19755

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2022

Event Type  malfunction  

Event Description

Lot 19755 of durolane (hyaluronic acid) had 2 syringes break during administration to patients.The back of the syringe shattered on two separate occasions.No patient harm has resulted from either incident.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 14117687
• MDR Text Key: 289493894
• Report Number: MW5109009
• Device Sequence Number: 2
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/13/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 19755
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other