MAUDE Adverse Event Report: CARDINAL HEALTH SANTA CLARA MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR

Model Number N/A

Device Problem Premature Activation (1484)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

This device is reported to not be available for analysis and no device has been received at the time of this report.An image has been received but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the sealant protection plastic of a 5f mynx control vascular closure device (vcd) was bent out of place when the customer opened it.The user did not attempt to use these on the patient.There was no reported patient injury.There was no damage observed to the packaging.There was no difficulty removing the device from the packaging.The device was not manipulated in any way prior to noticing the damage.The device will be returned for analysis.Addendum: preliminary review of the image received demonstrates that one of the sealant sleeves was bent outward, exposing the sealant.

• Brand Name: MYNX CONTROL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 19135546
• MDR Text Key: 340514270
• Report Number: 3004939290-2024-00196
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: 20862028000424
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MX5060
• Device Lot Number: F2402901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1