MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ULTRAPERC SINGLE STAGE DILATOR KIT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 100/563/080

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

Event Description

It was reported that, after insertion of the tracheostomy tube, the physician inflated and the cuff dislocated, changing the shape of the tube.Medical intervention was necessary to prevent patient injury.

• Brand Name: PORTEX ULTRAPERC SINGLE STAGE DILATOR KIT
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 13505671
• MDR Text Key: 286773597
• Report Number: 3012307300-2022-03104
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: 100/563/080
• Device Lot Number: 4118322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1