MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOBRONCHIAL TUBES; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION

Model Number 198-37L

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 06/01/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the customer noticed the end caps (a blue one and a transparent one) were attached to the wrong tubes respectively.No patient injury reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).No problem or issues were identified during the device history record review.Two photos and a product sample was received for evaluation.The sample was received in used condition without original package.During visual inspection, (under normal conditions of illumination) incorrect assembly was found.The blue end cap was attached to the tracheal tube, and the transparent end cap to the bronchial tube; the complaint was confirmed.No other analysis was performed.The potential cause of this failure condition could be caused by not following the method (procedure).All mitigations in place were verified and it was confirmed that it was executed accordingly.This failure condition will be monitored for threshold or escalation.Also, a customer complaint notification was performed.

• Brand Name: PORTEX ENDOBRONCHIAL TUBES
• Type of Device: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION
• 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: 16852505
• MDR Text Key: 314363680
• Report Number: 3012307300-2023-04861
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 15019315058622
• UDI-Public: 15019315058622
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953483
• 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: 05/02/2023

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 Expiration Date: 06/09/2023
• Device Model Number: 198-37L
• Device Catalogue Number: 198-37L
• Device Lot Number: 3990327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1