MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX

Model Number MX9505T

Device Problem Leak/Splash (1354)

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

Event Date 10/18/2021

Event Type  malfunction  

Event Description

It was reported that during the use process it was found that the waveform of invasive blood pressure was poor.Check the 2cm return blood in the arterial catheter, check whether the pressure bag was under pressure, and re squeeze it to 300mmhg.During the process, it was obvious that there was air leakage in the tee pipe, so it was replaced immediately.

Manufacturer Narrative

No product returned or picture provided for investigation.No dhr review completed as no product returned.

• Brand Name: MEDEX
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: david halverson ; 6000 nathan lane north; longgang district; minneapolis, MN 55442
• MDR Report Key: 13049142
• MDR Text Key: 282554240
• Report Number: 3012307300-2021-13056
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: 10351688503992
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2021

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 Model Number: MX9505T
• Device Lot Number: 3764508
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male