MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE (HYALURONIC ACID) INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Lot Number	21934
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Durolane (hyaluronic acid) 60mg/3 ml syringe was defective.Provide pulled cap off and the needle hub came off with at the same time, so needle could not be put on the syringe.

• Brand Name: DUROLANE (HYALURONIC ACID) INJECTION
• Common Device Name: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 19152354
• Report Number: MW5154030
• Device Sequence Number: 7445748
• Product Code: MOZ
• UDI-Device Identifier: 89130-2020-1
• UDI-Public: 89130-2020-1
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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 Expiration Date: 08/31/2026
• Device Lot Number: 21934
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown