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

Model Number MX9505T

Device Problem Leak/Splash (1354)

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

Event Date 07/15/2020

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two product sample were received for evaluation.Visual and functional testing were performed.It was observed that a component from a subassembly had lack of solvent on the tube.One sample from the two was found leaking on the subassembly when doing a water leak test.Relevant documents were reviewed and deemed adequate and correct with respect to investigation activities.The complaint is confirmed.The most likely root cause is related to a supplier issue.Operator of device unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: 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; minneapolis, MN 55442
• MDR Report Key: 15397881
• MDR Text Key: 300595643
• Report Number: 3012307300-2022-18562
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/14/2022
• Device Model Number: MX9505T
• Device Catalogue Number: MX9505T
• Device Lot Number: 3833910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1