MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; MONITORING

Model Number MX9505T

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation completed on a smiths pressure monitoring|medex transtar kits complaint of sensor suddenly detaches in the middle was not confirmed.Sample was used for analysis and during testing of water leak test, no leak was observed.Pictures were attached.Reviewed manufacturing assembly and device passes at 100 percent prior to release.Root cause of event was not determined as complaint could not be verified.Deployment to operators and quality inspectors in regards this failure mode, recorded on folio 13843 completed on 02/jun/21.

Event Description

Information received a smiths medical pressure monitoring|medex transtar kits was reported that when the nurse turns over (without pulling), the pressure sensor suddenly detaches in the middle.No adverse patient effects were reported.

• Brand Name: MEDEX
• Type of Device: MONITORING
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12385872
• MDR Text Key: 268734971
• Report Number: 3012307300-2021-08961
• 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,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: MX9505T
• Device Catalogue Number: MX9505T
• Device Lot Number: 4044988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2020
• 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