MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; TRACHEOSTOMY TUBE

Model Number 100/123/515

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

Information received a smiths medical portex single use bougie was used during a procedure of intubation for a patient receiving breast enlargement.The event became critical after the intubation and surgery completed.Recorded and reported to the adaptive network security management that the patient had a tracheal wound 2-3 cm below the vocal cords at 6 cm and developed subcutaneous emphysema of face and upper limbs.The patient required clinical monitoring, biological treatment for ten days,along with antibiotic therapy.This was a result of free air or gas entering the space in the body as result of wound in trachea.Additional information is being sought on the event of difficult tracheal intubation.No further adverse patient effects were reported.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10834224
• MDR Text Key: 216083250
• Report Number: 3012307300-2020-11417
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100/123/515
• Device Catalogue Number: 100/123/515
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention