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

Catalog Number 100/563/080

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Stenosis (2263)

Event Type  Injury  

Event Description

It was reported the device was placed in use with patient.The reporter stated the patient developed tracheal stenosis.According to reporter the patient required the device to be removed and replaced with a conventional tracheal tube to continue ventilation.Reporter stated upon removal the device cuff was found to be broken.No further adverse effects to patient reported.

• Brand Name: PORTEX ULTRAPERC PDT TRACHEOSTOMY 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10766838
• MDR Text Key: 214079061
• Report Number: 3012307300-2020-10868
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K041348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/563/080
• Device Lot Number: 3821336
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention