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  

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

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.

Manufacturer Narrative

D9: date returned to mfg.: 1/29/2024.H3 and h6.Evaluation codes: updated.Device evaluation: one used device sample outside its original package was received for evaluation.The returned sample failed and electrical, vacuum and air leak testing.The returned device did pass a water leak test.Through the device analysis executed it was found that the returned sample failed the electrical test.The complaint was confirmed.The root cause was a welding defect during manufacturing.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Awareness was given to personnel who perform the assembly process.E1 - phone.

• 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: 18539184
• MDR Text Key: 333520903
• Report Number: 9616567-2024-00012
• Device Sequence Number: 1
• Product Code: DPT
• UDI-Device Identifier: 10351688503992
• UDI-Public: (01)10351688503992(17)250725(10)4299814
• 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: 04/08/2024

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: 4299814
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• 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