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

Catalog Number 100-813-060

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that the inner cannula was broken.There was no patient injury reported.

Manufacturer Narrative

One tracheostomy tube was received for evaluation in relation to the reported event.The device was received in plastic bag without its original packaging.Under visual inspection we noticed that there is crack between two fenestrated holes.The reported event was able to be confirmed.Root cause was unable to be determined as the thickness of the cannula walls was within specification.The damage may have been caused during incorrect cleaning procedure.A dhr review was not completed as no lot information was available.

Manufacturer Narrative

One tracheostomy tube was received for evaluation in relation to the reported event.The device was received in plastic bag without its original packaging.Under visual inspection we noticed that there is crack between two fenestrated holes.The reported event was able to be confirmed.Root cause was unable to be determined as the thickness of the cannula walls was within specification.The damage may have been caused during incorrect cleaning procedure.A dhr review was not completed as no lot information was available.

Event Description

It was reported that the inner cannula was broken.There was no patient injury reported.

• Brand Name: PORTEX
• 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; minneapolis, MN 55442
• MDR Report Key: 13548839
• MDR Text Key: 286138390
• Report Number: 3012307300-2022-03534
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100-813-060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1