MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR PRESSURE TRANSDUCER; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Model Number MX9505T

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/08/2021

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, a supplemental report will be filed.

Event Description

It was reported that leakage was found during use.No patient injury was reported.

• Brand Name: MEDEX TRANSTAR PRESSURE TRANSDUCER
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• 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: jim vegel ; 6000 nathan lane north; dongying district; minneapolis, MN 55442
• MDR Report Key: 15198809
• MDR Text Key: 300127708
• Report Number: 3012307300-2022-15144
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2022

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 Catalogue Number: MX9505T
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1