MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL INFLOW TUBING FMS VUE 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE

Model Number 284508

Device Problem Increase in Pressure (1491)

Patient Problem Not Applicable (3189)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by affiliate via personal interaction that inflow liquid came into the connecting section of the inflow tubing (inflow tubing fms vue 24pk), so the unit just kept draining the inflow liquid.The 1st replacement (284508) malfunctioned the same.Finally the 2nd replacement functioned normally.The procedure was completed less than 30-minute surgical delay.There was no harm to the patient.The devices were the first use when the issue occurred.Additional information reported by the affiliate stated the devices will not be returning for evaluation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the complaint device is not being returned, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (6053), 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.Device history lot a manufacturing record evaluation was performed for the finished device lot number (6053), and no non-conformances were identified.

• Brand Name: INFLOW TUBING FMS VUE 24PK
• Type of Device: SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10054005
• MDR Text Key: 205695771
• Report Number: 1221934-2020-01371
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

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: 02/27/2021
• Device Model Number: 284508
• Device Catalogue Number: 284508
• Device Lot Number: 6053
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/01/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 05/28/2020
• Patient Sequence Number: 1