MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. MEDEX TRANSTAR KITS; PRESSURE MONITORING

Catalog Number MX9505T

Device Problem Data Problem (3196)

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

Event Date 11/11/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the device had displayed no data during use.No harm was done to the patient and the faulty product was replaced with a new set.There was patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

D9.Date returned to mfg: 29-jan-2024.Investigation summary: one used sample outside its original package was received at monterrey site for evaluation.Electrical testing performed.The returned sample was found accepted during electrical test.Vacuum testing performed.The returned sample was found rejected during testing.Air leak testing performed.The returned sample was found accepted during testing.Water leak test at 15 psi performed.The returned sample was found rejected during testing as the part exhibit leakage on pn: a950-02.Electrical board visual inspection performed.The returned sample was visually inspected by removing cover pn: 300-288 to verify the solder appearance.Solder application was observed to be correctly applied.Complaint is confirmed for the failure mode reported ¿the device had displayed no data during use¿ through the device analysis executed it was found that returned sample exhibited leakage defect on pn: a950-02.A capa was initiated to investigate root cause of electrical and leakage issues on transtar assembly a950-02.The device history record of reported lot 4299815 was reviewed and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Dhr of lot 4307045 used subassy a950-02, which is related to condition reported was reviewed.As part of the process product is inspected 100% electrically and 100% for vacuum test.Results of these lots were reviewed and were found within specifications.

• Brand Name: MEDEX TRANSTAR KITS
• Type of Device: PRESSURE MONITORING
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18539487
• MDR Text Key: 333322870
• Report Number: 9616567-2024-00015
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: (01)10351688503992(17)250725(10)4299815
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: 4299815
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2022
• 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