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

Model Number MX9505T

Device Problem Defective Component (2292)

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

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

Phone: (b)(6).

Event Description

Information was received indicating that a smiths medical probe had a broken pressure sensor.It was replaced and there were no reported adverse events.

Manufacturer Narrative

Other text: investigation completed on a smiths pressure monitoring|medex transtar kits.The complaint of pressure sensor found to be broken was not confirmed.Five pictures were reviewed and shoed female luers disconnected from tube and a pressure transducer broken (transtar and trigger flush), however these parts were not sent for analysis.Visual inspection could not confirm complain on sample provided, as no damage was observed.Assembly revealed product passed 100 percent prior to release.Root cause: the root cause of the reported issue cannot be determined, as the returned sample did not exhibited breakage and the samples from pictures were not provided for evaluation in order to identify the cause of the damage.

Event Description

Investigation completed and summary in h 10.

• Brand Name: MEDEX
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 12042227
• MDR Text Key: 257497978
• Report Number: 3012307300-2021-06381
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: 10351688503992
• Combination Product (y/n): N
• PMA/PMN Number: K942377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• 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: 4072632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1