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

Model Number 100/800/075

Device Problem Inflation Problem (1310)

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

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

No device was returned for investigation.

Event Description

It was reported that during usage: the patient supine, shoulder pads, exposed area, anterior portion from two horizontal refers to the edge of thyroid cartilage to operating a long, ca.4 cm incision expose thyroid gland, the thyroid, exposed the trachea front fascia, separation of tracheal front fascia, exposed the trachea, with 5 syringe needle puncture pumping back to confirm, tracheal incision 3-4 trachea ring, open the trachea incision, no.7 disposable tube was inserted, the tube core was pulled out, and the air bag could not be inflated when the tube was fixed.

Manufacturer Narrative

Other, other text: the lot number reported was not found.Device history record review was not performed.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• 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: david halverson ; 6000 nathan lane north; lengshuitan district; minneapolis, MN 55442
• MDR Report Key: 12971971
• MDR Text Key: 282098297
• Report Number: 3012307300-2021-12555
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

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
• Device Operator: Health Professional
• Device Model Number: 100/800/075
• Device Catalogue Number: 100/800/075
• Device Lot Number: 3778355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 09/12/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male