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

Model Number	HU16DS50NSA245N
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: listed as "home care".Report source: foreign: (b)(6).(b)(4).
Event or Problem Description
Information was received that a smiths medical portex bivona custom tracheostomy tube material is "rubbing" while in use with a patient.It was also noted that the patient's mother observed an appearance of "bubbles/nodules on one side".No additional adverse patient effects were reported.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Visual inspection of the device found it to have biological matter and chips on the shaft reference pictures.The shaft was inspected for bubbles and nodules.No bubbles were identified within the formed shaft, but chips on the outside were identified.Review of manufacturing materials confirmed that there has been no change to the silicone or adhesives used to build the device.Factors that may affect the durability of the silicone are the use of petroleum based lubricants and cleaners, and medications that are administered to the end user.The reported customer complaint has been confirmed, and the problem source has been determined to be unknown.The condition of the returned device appeared to be the result of use and not the result of improper manufacturing.

• 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: 8733176
• Report Number: 3012307300-2019-02723
• Device Sequence Number: 13982042
• Product Code: JOH
• UDI-Device Identifier: 15019517144352
• UDI-Public: 15019517144352
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2019

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: Lay User/Patient
• Device Expiration Date: 03/19/2023
• Device Model Number: HU16DS50NSA245N
• Device Catalogue Number: HU16DS50NSA245N
• Device Lot Number: DS014756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 08/22/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1