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

Catalog Number	CMZ2052N
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the bivona tracheostomy tube had a broken collar.No reported adverse effects.
Additional Manufacturer Narrative
Changed from product problem to adverse event as the additional information states there was a cannula change.Changed to serious injury.Device evaluation: one portex® bivona customization tracheostomy tube was returned for analysis.The customer's reported problem was "the collar was broken".Upon visual inspection, it was noticed that both of the neck flange eyelets were torn.One was completely through and the other only partially.From the sample, it appears the neck flange eyelets were torn through by something sharp cutting through both of the eyelet holes.The directions for use contains a warning statement to guard against product damage by avoiding contact with sharp edges.The manufacturing and quality inspection processes were reviewed and considered adequate and correct.
Event or Problem Description
The incident did not cause clinical consequences for the patient and did not aggravate the patient's condition.The cannula was replaced by a cannula in stock.The issue is not resolved, but is still in progress.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: 7611391
• Report Number: 3012307300-2018-02465
• Device Sequence Number: 16380088
• Product Code: JOH
• UDI-Device Identifier: 15019517124095
• UDI-Public: 15019517124095
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

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?: Yes
• Operator of Device: No Information
• Device Expiration Date: 02/14/2023
• Device Catalogue Number: CMZ2052N
• Device Lot Number: DS013691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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