MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX RESPIRATORY INTRODUCERS AND GUIDES; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/123/515

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem Airway Obstruction (1699)

Event Date 12/05/2020

Event Type  malfunction  

Manufacturer Narrative

Udi section and device lot number are unknown, no product information has been provided to date.No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that the icu physician attempted to utilize bougie during a difficult intubation where the patient's airway was anterior.Upon arriving at the cord, the bougie did not retain its rigidity and curved instead of continuing on to the airway to facilitate intubation.Physician felt that this equipment did not perform in the manner it would be expected as previous bougies did not behave in this fashion.This caused delay in capturing the airway with some desaturation by the patient.No serious harm was reported.

• Brand Name: PORTEX RESPIRATORY INTRODUCERS AND GUIDES
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15580699
• MDR Text Key: 306690258
• Report Number: 3012307300-2022-23253
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/11/2022

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 Catalogue Number: 100/123/515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/11/2022
• 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