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

Catalog Number	670185
Medical Device Problem Code	Hole In Material (1293)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the cuff of a portex® bivona® adult tts¿ tracheostomy tube "had been pierced" after a few days.The patient had difficulty breathing at the time of the event.The tracheostomy tube was replaced.No permanent injury was reported.
Additional Manufacturer Narrative
One portex bivona adult tts tracheostomy tube was returned for analysis in used condition.Visual inspection of the device identified some wear on the cuff.After testing, a leak was detected on the cuff.Using magnification, the area of the leak was inspected showing abrasion marks and appeared to have been worn away.The investigation could not determine what caused the wear on the cuff (i.E.Scrubbing during cleaning, rubbing on cartilage in the trachea, etc.).Manufacturing 100% leak tested the lot of devices and quality performed a leak test on a sample of the lot.If the wear had been present, the device would have failed.The investigation could not determine how the cuff became worn.

• Brand Name: PORTEX® BIVONA® ADULT TTS¿ 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: 6862275
• Report Number: 3012307300-2017-02033
• Device Sequence Number: 898626
• Product Code: JOH
• UDI-Device Identifier: 15021312006087
• UDI-Public: 15021312006087
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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: No Information
• Device Expiration Date: 02/13/2022
• Device Catalogue Number: 670185
• Device Lot Number: 3370211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 12/08/2017
• 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
• Patient Age: 24 YR
• Patient Weight: 70