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

Catalog Number 100/512/090

Device Problem Break (1069)

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

Event Type  Injury  

Event Description

It was reported that after two days of use, the white cuff broke.Additional information received indicated that medical intervention was required.The tracheostomy tube was changed at the patient's home by the doctor.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Three (3) product photos were received for evaluation.Visual inspection found none of the top view photos of the packaging show the condition of the cuff and it is not possible confirm the failure mode reported by customer.No functional testing could be performed as no samples were received.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX BLUE LINE TRACHEOSTOMY TUBES
• 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): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14655671
• MDR Text Key: 294121363
• Report Number: 3012307300-2022-11554
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/512/090
• Device Lot Number: 4007562
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/10/2022
• Supplement Dates Manufacturer Received: 08/05/2022; 06/14/2023
• Supplement Dates FDA Received: 09/02/2022; 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention