MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 101/860/070CZ

Device Problem Break (1069)

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

Event Date 12/11/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation of this complaint was limited because no sample was returned.Customer provided three photos which showed a visible break of the flange connection.There is also shown broken inflation line which had to lead to cuff deflation.The problem source cannot be identified.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.

Event Description

It was reported that nurses noted right flange to portex trach broke away from connector ring, trach remained in place and stable, anchored well from other side.Informed immobile, reviewed by immobile consultant.Flange snapped on right side from connector ring.Note tube was inserted on (b)(6) 2021.

Manufacturer Narrative

Investigation of this complaint was limited because no sample was returned.Customer provided three photos which showed a visible break of the flange connection.There is also shown broken inflation line which had to lead to cuff deflation.The problem source cannot be identified.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.

Event Description

It was reported that nurses noted right flange to portex trach broke away from connector ring, trach remained in place and stable, anchored well from other side.Informed immobile, reviewed by immobile consultant.Flange snapped on right side from connector ring.Note tube was inserted on (b)(6) 2021.

• Brand Name: BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; denmark hill; minneapolis, MN 55442
• MDR Report Key: 13497524
• MDR Text Key: 285333673
• Report Number: 3012307300-2022-02957
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: 15019517076134
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• 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: 4062929
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1