MAUDE Adverse Event Report: SMITHS MEDICAL, INC. TRANSTAR PRESSURE MONITORING SYSTEM; DPT - PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number MX9505T

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A report was received stating during set-up, tubing separation occurred at the male luer lock.As this issue was found during set-up, there was no patient involvement.

Manufacturer Narrative

The device was not returned to the manufacturer for device evaluation.When and if the device becomes available and is returned for evaluation, the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: TRANSTAR PRESSURE MONITORING SYSTEM
• Type of Device: DPT - PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL, INC.; dublin OH
• Manufacturer (Section G): SMITHS MEDICAL; 6250 shier-rings road; dublin OH 43016
• Manufacturer Contact: pete hirte ; 1265 grey fox road; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4379713
• MDR Text Key: 5114344
• Report Number: 2183502-2014-01003
• Device Sequence Number: 1
• Product Code: DPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Catalogue Number: MX9505T
• Device Lot Number: 2473887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2014
• Event Location: Hospital
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1