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

Catalog Number	CM3294N
Medical Device Problem Codes	Material Fragmentation (1261); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a red rubber part snapped off causing balloon not to inflate on a portex® bivona customization tracheostomy tube.This was a regular tracheostomy change, but an emergency change was performed after cuff would not inflate.There was no patient injury with this occurrence.
Additional Manufacturer Narrative
One custom tracheostomy tube was returned for evaluation.Visual inspection found that the airway inflation port was completely detached from the airway line.It was observed that there was evidence of adhesive applied at the base of the inflation port.A review of the device history record was performed and found to be complete.Based on the evidence, a root cause was unable to be confirmed.It was suspected that the failure was due to insufficient bonding or excessive tensile force.

• Brand Name: PORTEX® BIVONA CUSTOMIZATION SERVICES
• 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: 6856008
• Report Number: 3012307300-2017-02013
• Device Sequence Number: 18991905
• Product Code: JOH
• UDI-Device Identifier: 15019517081428
• UDI-Public: 15019517081428
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2017

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: Health Professional
• Device Catalogue Number: CM3294N
• Device Lot Number: DS004125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention