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

Catalog Number	CMZ3162N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This single-use device is indicated to be reused on a single patient.
Event or Problem Description
It was reported that a portex® bivona® tracheostomy tube experienced a slow leak.The patient was not ventilating at all.The issue was observed spontaneously by the patient's mother and a registered nurse.The tracheostomy tube had been used before and was cleaned at the patient's home.Cuff patency was tested prior to use, and the cuff was filled with sterile water.The patient is ventilator dependent and cannot breathe without the tube in place.The patient experienced dyspnea.The patient was then bagged and the tracheostomy tube was replaced.No permanent injury was reported.
Additional Manufacturer Narrative
One device was returned for evaluation.Leak testing was performed and identified that the cuff inflated and slowly deflated as air escaped from the airway line on the side of the shaft.Microscopic inspection of the leak location found a tear on the inflation line.It was observed that the inflation line was still attached and adhesive was present on the device airway line joint, below the tear.Based on the evidence, a root cause was unable to be determined.The reported issue was observed during investigation.

• Brand Name: PORTEX® BIVONA® TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7212974
• Report Number: 3012307300-2018-00101
• Device Sequence Number: 1022302
• Product Code: JOH
• UDI-Device Identifier: 15019517120806
• UDI-Public: 15019517120806
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,health p
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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?: No
• Operator of Device: No Information
• Device Catalogue Number: CMZ3162N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 01/23/2018
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VELCRO NECK HOLDER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR
• Patient Weight: 37