MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUSELECT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number 101/860/070CZ

Device Problem Leak/Splash (1354)

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

Event Date 05/01/2021

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of air from the product was observed.Also, the cuff was unable to be inflated.There was no patient injury reported.

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.One decontaminated sample was received for investigation without its original packaging.Visual inspection confirmed that there was tear in the cuff.During the functional testing it was observed that it was not even possible to inflate the cuff because it leaked so badly.The most probable root cause of this defect occurred during manufacturing or packaging of this device, due to fact that cuff leak was detected by customer during pre-use check.No further action was taken.

• Brand Name: PORTEX TUBES BLUSELECT
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17019586
• MDR Text Key: 316120144
• Report Number: 3012307300-2023-05823
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: 15019517076134
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/070CZ
• Device Catalogue Number: 101/860/070CZ
• Device Lot Number: 4010067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1