MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX BIVONA AIRE-CUF TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	750160
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex® bivona® aire-cuf® tracheostomy tube could not be blocked during change out.There were no reported adverse effects.

• Brand Name: PORTEX BIVONA AIRE-CUF TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis,, mn
• MDR Report Key: 9845357
• Report Number: 3012307300-2020-02113
• Device Sequence Number: 19017800
• Product Code: JOH
• UDI-Device Identifier: 15021312006407
• UDI-Public: 15021312006407
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2020

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: 08/02/2023
• Device Model Number: 750160
• Device Catalogue Number: 750160
• Device Lot Number: 3677743
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1