MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR SINGLE MONITORING KIT; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Model Number MX9505T

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 04/30/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that on april 30, the patient was in respiratory cardiac arrest due to "sudden consciousness disorder for more than 30 minutes"; respiratory failure" after coming to the hospital, cardiopulmonary resuscitation and other rescue were performed, blood pressure was low after heart rate recovery, the nurse gave invasive blood pressure puncture, and cracks were found when the invasive blood pressure connection device was disassembled, and the connection device was replaced.

Manufacturer Narrative

Other text: h6 codes updated.No device was returned for investigation.Root cause unable to be determined.Device history review shows no non-conformities during the manufacturing process.

• Brand Name: MEDEX TRANSTAR SINGLE MONITORING KIT
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17056124
• MDR Text Key: 316477639
• Report Number: 3012307300-2023-06020
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: 10351688503992
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K942377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MX9505T
• Device Catalogue Number: MX9505T
• Device Lot Number: 4277681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male