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

Catalog Number	CM3289N
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/11/2017
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that during qa inspection, it was observed that the "cylindrical part in silicone against the iso-15 connector" of a portex® bivona® custom tracheostomy tube is "prolonged" than the standard mpt flange.Because the deviation was observed during a pre-use inspection, there was no patient involvement or injury.
Additional Manufacturer Narrative
One portex® bivona® custom tracheostomy tube was returned for analysis.The device was reviewed against the custom made template specification and also to the custom made drawing.The device was made according to the template and the drawing.The device measured within specification.The device history records were reviewed and showed the device passed quality inspections.The complaint file had comparative pictures between the returned custom made device and a standard neck flange.The custom made device is different and would have different dimensions than a device with a standard neck flange.Based on the evidence, the complaint was not confirmed.

• Brand Name: PORTEX® BIVONA® CUSTOM 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: 6641104
• Report Number: 3012307300-2017-01322
• Device Sequence Number: 1122720
• Product Code: JOH
• UDI-Device Identifier: 15019517080490
• UDI-Public: 15019517080490
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 04/07/2022
• Device Catalogue Number: CM3289N
• Device Lot Number: DS003995
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1