MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX TRANSTAR SINGLE MONITORING KIT, 84 INCH; PROBE, BLOOD-FLOW, EXTRAVASCULAR

Catalog Number MX9505T

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Zero (1683)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

H3: other: device has not been returned to date.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that the patient came to the hospital for radical surgery for left breast cancer.Preoperative anesthesia monitoring and invasive blood pressure monitoring on the left radial artery were performed.The puncture went smoothly.After the puncture was completed, the arterial blood pressure couldn't be adjusted to zero.Replacing the device with a new one solved the problem.There was patient involvement, but no harm/adverse event was reported.

• Brand Name: MEDEX TRANSTAR SINGLE MONITORING KIT, 84 INCH
• Type of Device: PROBE, BLOOD-FLOW, EXTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19101360
• MDR Text Key: 340707737
• Report Number: 1526863-2024-00023
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: (01)10351688503992(17)250926(10)4323180
• 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: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX9505T
• Device Lot Number: 4323180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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
• Patient Age: 57 YR
• Patient Sex: Female