MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY

Model Number ENDOBRONCHIAL-TUBE 32-FRENCH

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

Information received a smiths medical intubation|portex endobronchial tube immediately upon the use of the product, the customer noticed the slip joint was partially deformed.No patient injury.

Manufacturer Narrative

One portex endobronchial tube was returned for analysis in used condition.Visual inspection revealed that a plastic burr was noted in the connector.Relevant documents were reviewed and deemed adequate.An audit of the production floor was performed, and the following operations were reviewed: connector assembly operation, training record of operators who perform the connector assembly operation, training records of operators who perform packaging operation, packaging operation, and the production line.All operations that were reviewed resulted with no discrepancies.During the manufacturing process, 32 samples were reviewed in order to verify that the connector did not have a burr; no discrepancies noted.Based on the evidence, the complaint was confirmed.However, the root cause is unknown.It was found to be thought that the sample became damaged after leaving the shm facility.

Manufacturer Narrative

Other text: correction: one portex endobronchial tube was returned in used condition and three (3) photo for investigation.Visual inspection of the sample and photos revealed a plastic blur in the connector.There were two (2) probably root causes, the product was damaged after leaving the manufacturing site and possible missed detection during the packaging process.As action, the manufacturing site conducted retraining to the production personnel on the packaging process.A device history record (dhr) review was performed which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4), corrected data: h6 and h10.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: david halverson ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 10258247
• MDR Text Key: 198347630
• Report Number: 3012307300-2020-07162
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 15019315058608
• UDI-Public: 15019315058608
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ENDOBRONCHIAL-TUBE 32-FRENCH
• Device Catalogue Number: 198-32L
• Device Lot Number: 3877693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1