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	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that eight days following placement of a smiths medical portex bivona ¿ tts¿ tracheostomy tube the pilot balloon was noted to break off.Subsequently, it was required to perform an emergent tracheostomy (trach) change.There were no reported adverse effects.

• 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: 7594219
• Report Number: 3012307300-2018-02251
• Device Sequence Number: 2018735
• 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
• Report Date (Section B): 06/12/2018

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/12/2018
• 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