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

Lot Number	DS007359
Medical Device Problem Codes	Break (1069); Tear, Rip or Hole in Device Packaging (2385); Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tracheostomy tube is for single patient use, but can be used multiple times on the same patient.See mfr: 3012307300-02460 and 3012307300-2017-02461.
Event or Problem Description
It was reported that while a patient was using a portex® bivona custom tracheostomy tube, the flange broke.An emergency trach change was performed.There was no patient injury.
Event or Problem Description
The event occurred while the patient was sleeping or "up, awake, and [acute]".The device failed within 7 days of use.
Additional Manufacturer Narrative
Correction: the following are the actual catalog number and lot numbers for the products returned for analysis.Part number su17gn40ngf123s is for a 4.0 device.The lot number associated with this part number is ds007358.(two devices manufactured) part number su17gn35ngf124s is for a 3.5 device.The lot number associated with this part number is ds007359.(one device manufactured) both part numbers are for same patient.Both dhr's were reviewed and were found within specification and passed quality inspection.

• 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: 7059703
• Report Number: 3012307300-2017-02438
• Device Sequence Number: 1423477
• Product Code: JOH
• UDI-Device Identifier: 15019517116199
• UDI-Public: 15019517116199
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2018

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?: Yes
• Operator of Device: Patient Family Member or Friend
• Device Expiration Date: 08/11/2022
• Device Lot Number: DS007359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Supplement Date Received by Manufacturer: 11/29/2017; 01/03/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 12/05/2017; 01/08/2018
• 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: 7 YR
• Patient Weight: 22