MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TRANSTAR PRESSURE MONITORING KITS; 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 fluid leaked during use of the pressure monitoring device.No patient injury was reported.

Manufacturer Narrative

Two samples were received to perform an investigation.Testing of the returned samples for leakage found one sample leaking from a subassembly.Visual inspection of the device found a lack of solvent on the tube.A device history record (dhr) review was conducted which indicated that rework was executed during the manufacturing of this lot.Air leak test for rework found no pieces defective.The complaint was confirmed and the supplier was determined to be the source of the problem.Notification and training was given to the production workers.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.

• Brand Name: TRANSTAR PRESSURE MONITORING KITS
• 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: 15397878
• MDR Text Key: 306078254
• Report Number: 3012307300-2022-18558
• 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: 08/02/2022
• Device Model Number: MX9505T
• Device Catalogue Number: MX9505T
• Device Lot Number: 3857200
• 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: 08/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1