MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BIVONA® CUSTOM ADULT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problems Product Quality Problem (1506); Defective Component (2292); Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).

Event Description

It was reported that a portex® bivona® custom adult tracheostomy tube was not ventilating the patient properly.It was noted that the tracheostomy tube had an incorrect angle on the flange/shaft and the silicone stoma seal was on the outside of the flange instead of the inside.This resulted in the tracheostomy tube not fitting the patient correctly.The event resulted in tracheal irritation and bleeding and an emergency tracheostomy tube change was required.No permanent injury was reported.See mfr: 3012307300-2016-00396.

Manufacturer Narrative

No product was returned for investigation; however, a photographic image was provided for review.Although no lot number was provided, a review of all lots associated to the reported part number found no abnormalities or non-conformities during manufacturing.A review of the provided photograph, compared to the device drawing, showed a difference in the flange position and the flextend¿ length.Investigation determined that root cause of the reported issue was due to manufacturing and the device drawing should be modified to include the patient's preferred angle of the neck flange.

• Brand Name: PORTEX® BIVONA® CUSTOM ADULT TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6135945
• MDR Text Key: 61141549
• Report Number: 3012307300-2016-00395
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/04/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention