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

Lot Number 21804

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

Event Date 11/07/2023

Event Type  malfunction  

Event Description

Spontaneous: medical assistant (b)(6) from md office reports that the glass syringe broke on (b)(6) 2023 when doctor tried to give his injection and pt did not get injured, but he did not receive the full dose.Unknown if the defective syringe is available for return for inspection.Unknown reason for the syringe breaking.Unknown why the pharmacy was not notified until now.No adverse event reported.No further information provided.Indication: unilateral primary osteoarthritis, right knee.Reported to (b)(6) by health professional.

• Brand Name: DUROLANE PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 19059996
• MDR Text Key: 339684989
• Report Number: MW5153612
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2024

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 Operator: Health Professional
• Device Lot Number: 21804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male