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

Catalog Number	HT14KS60NSC287S
Medical Device Problem Code	Cut In Material (2454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that three days following placement of a smiths medical portex bivona ¿ tts¿ tracheostomy tube, a cut was noted to the pilot line.Subsequently, it was required to perform an emergent tracheostomy (trach) change.There were no reported adverse effects.
Additional Manufacturer Narrative
One custom tracheostomy tube was received for device evaluation.Visual inspection revealed a cut / tear at the pilot line, apparently caused by a sharp edge.There was no evidence to suggest excess tensile force or stretching of the pilot line.Custom devices are 200 percent inspected prior to packaging and release for distribution.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX BIVONA ¿ TTS¿ TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7594232
• Report Number: 3012307300-2018-02252
• Device Sequence Number: 232375
• Product Code: JOH
• UDI-Device Identifier: 15019517022605
• UDI-Public: 15019517022605
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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 Expiration Date: 09/01/2022
• Device Catalogue Number: HT14KS60NSC287S
• Device Lot Number: DS008071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR
• Patient Weight: 57