MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC MONOVISC 4 ML US; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION

Catalog Number 690016

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

This case is still under investigation.A supplemental report will be submitted upon completion of the investigation by the manufacturing plant.

Event Description

On (b)(6) 2022 it was reported to anika that during an injection, the luer lock of the syring broke.The needle was attached to the leur lock.The solution leaked onto the floor.A 20 gauge needle was used.There was no guidance used when performing the injection.There was no report of any damage to the device packaging or device.There was no negative patient impact reported and the procedure was completed with no delay.Additional information was solicited.

Manufacturer Narrative

This case is still under investigation.A supplemental report will be submitted upon completion of the investigation by the manufacturing plant.Additional information 20april2022: the reported event is not confirmed.It was reported that the device broke at the tip and leaked.A review of the photo provided indicates a crack in the leur but no clear breakage.The device was not returned for evaluation at the manufacturing plant.There was no report of any patient or user impact.Additional information was not provided upon request.A review of the device batch record was performed.There was no nonconformance or planned deviations documented in the manufacturing record.All product all product manufactured by anika and anika entities are released to applicable procedures and specifications.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.

Event Description

On 03mar2022 it was reported to anika that during an injection, the luer lock of the syring broke.The needle was attached to the leur lock.The solution leaked onto the floor.A 20 gauge needle was used.There was no guidance used when performing the injection.There was no report of any damage to the device packaging or device.There was no negative patient impact reported and the proceedure was completed with no delay.Additional information was solicited.

• Brand Name: MONOVISC 4 ML US
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS INC; 32 wiggins avenue; bedford MA 01730
• Manufacturer (Section G): ANKIA THERAPEUTICS INC; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 13904910
• MDR Text Key: 295807756
• Report Number: 3007093114-2022-00002
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 690016
• Device Lot Number: 0000005200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1