MAUDE Adverse Event Report: DEPUY MITEK LLC US INFLOW TUBING FMS VUE 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number 284508

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).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

It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2020, it was observed that the inflow tubing device was leaking at the hose attachment above the chamber.It was only filled with saline solution without patient contact.There was a five minute surgical delay.Another like device was available and used without issues.There were no adverse patient consequences reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Event Description

It was reported by the affiliate in germany that preoperatively to an unknown surgery on (b)(6) 2020, it was observed that the inflow tubing device was leaking at the hose attachment above the chamber.It was only filled with saline solution without patient contact.There was a five minute surgical delay.Another like device was available and used without issues.There were no adverse patient consequences reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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 mitek or its employees that the report constitutes an admission that the device, 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: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the hose connection was discovered to be leaky pre-operatively.Therefore, the event description has been updated accordingly.

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 mitek or its employees that the report constitutes an admission that the device, 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: 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.

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 mitek or its employees that the report constitutes an admission that the device, 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.Investigation summary: according to the information provided, it was reported that device was leaking at the hose attachment above the chamber.The complaint device was received and evaluated.The hose was installed to check the functionality and a leak was detected between the expansion chamber and in the bracket area's.When a picture under magnification was taken a slight crack was found in the expansion chamber.The complaint can be confirmed.The possible root cause for the reported failure can be attributed to sharp edges in the bracket of the pump or the device had contact with other sharp metal instrument.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [7563] number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: INFLOW TUBING FMS VUE 24PK
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10718294
• MDR Text Key: 212520563
• Report Number: 1221934-2020-03162
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705023066
• UDI-Public: 10886705023066
• Combination Product (y/n): N
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2021
• Device Model Number: 284508
• Device Catalogue Number: 284508
• Device Lot Number: 7563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1