MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE); SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number 284508

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/06/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).Reporter is a j&j employee.The device manufacture date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

This is report 2 of 2 for (b)(4).It was reported by the affiliate in japan that preoperatively to an unknown procedure for calcinosis inflammation on (b)(6) 2023, it was observed that the fill chamber on two surgical irrigation tubing set, general-purpose devices had black stains on them.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary : both photo of the complaint device and the actual complaint device were received and evaluated.Upon visual inspection of the photos, it was observed that the device had a black dot in the fill chamber, the photos showed that device was still packed.The complaint device was received new with its original sealed primary packaging.Upon visual inspection it was observed that the device had a label on the packaging that pointed to a black dot in the fill chamber.The device was sent to the qa analytical laboratory for its chemical identification, infrared analysis was carried out in accordance with laboratory test method ltm-0002 rev.E "identification of materials by infrared spectroscopy" and the use of ft-ir instrument was performed in accordance with qap-0706 rev.D.Overall, ir data reveals that unknown material is principally composed of polyvinyl acetate-base material.The source of origin presumably is the ink used in device graphics.Comparison test showed that unknown material shared all the principal peaks associated to ink used in device graphics.These results suggest that unknown material is a printing error in device.The manufacturer performed an investigation with the following results: all personnel responsible for the printing process of the expansion chamber (p/n h3101350) were trained to documented work instructions.Operators are instructed to visually inspect the artwork and expansion chamber for smearing, peeling and flaking.All personnel responsible for traying the tubeset (p/n 284508) were trained to the documented work instructions.Operators are instructed to visually inspect the device for foreign matter.The black marks observed in the complaint photo are black in color.It is possible to these are ink particles from the pad printing process of the expansion chamber.The printing machine was reviewed on the production floor.The cliche is causing dry ink to fall over the nest as the ink residue accumulates over time.According with visual inspection of the photos and the supplier manufacturing investigation, this complaint can be confirmed.The black dot in the expansion chamber was attributed to the dry ink that fall over the nest as the ink residue accumulates in the printing machine.This product issue is already being addressed by depuy quality system.According with the supplier manufacturing investigation and ft-ir results this complaint can be confirmed.The black dot in the expansion chamber is attributed to the dry ink that fall over the nest as the ink residue accumulates in the printing machine.This product issue is already being addressed by depuy quality system.A dhr review of the tubeset lots 3002809 and 3002690 showed no similar findings.In addition, a dhr review of the expansion chamber lots 3002554, 3002472 and 3002473 used to manufacture the tubeset showed no similar findings.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FMS FLUID MANAGEMENT SYSTEM INFLOW TUBING (FMS VUE)
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16242624
• MDR Text Key: 308713399
• Report Number: 1221934-2023-00490
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705023066
• UDI-Public: 10886705023066
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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 Expiration Date: 09/29/2023
• Device Model Number: 284508
• Device Catalogue Number: 284508
• Device Lot Number: 3002690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/25/2023
• Supplement Dates Manufacturer Received: 02/10/2023; 03/27/2023; 03/28/2023
• Supplement Dates FDA Received: 02/13/2023; 03/28/2023; 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1