MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUSELECT DILATION TRACHESTOMY KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/800/090CZ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the retaining eyelet for fastening the cannula retaining band was torn open.This caused the retaining strap to come loose and a secure hold of the cannula in the trachea was no longer guaranteed.No injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual inspection found the tape eye on tracheostomy tube flange is broken.Such defect might be related to supplied item injection moulding process or to handling during use.The failure is considered to be isolated incident with unknown root cause.No actions are planned at this time.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
Additional information received via e-mail on 11-aug-2022: a trach change took place - this was mandatory because the retraining strap could no longer be attached.The change solved the problem for the time being.

• Brand Name: PORTEX BLUSELECT DILATION TRACHESTOMY KIT
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15104080
• Report Number: 3012307300-2022-14196
• Device Sequence Number: 12119511
• Product Code: BTO
• UDI-Device Identifier: 15019517076110
• UDI-Public: 15019517076110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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
• Operator of Device: Health Professional
• Device Model Number: 101/800/090CZ
• Device Catalogue Number: 101/800/090CZ
• Device Lot Number: 4197025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown