MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC SILICONE - BIVONA TUBES CUSTOM TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FT17AN40NGE057N
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation results: per the customized dfu (pkg-dfu-cfx-2) warning statement in section 4.10 "guard against product damage by avoiding contact with sharp edges.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity.A damaged eyelet can result in decannulation of the tracheostomy tube.Smiths medical recommends using the twill tape holder supplied with the product." the product is 100% inspected after manufacturing, prior to shipping to the customer.
Event or Problem Description
It was reported the flange of the tracheostomy (trach) tube was torn.Subsequently, a trach change out was required.No adverse patient effects were reported.
Additional Manufacturer Narrative
Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed the device's eyelets were torn completely through.Customers reported issue was confirmed a damaged eyelet can result in decannulation of the tracheostomy tube.It is recommended that the provided smiths medical twill tape be used to secure the neck flange.The root cause of the reported issue was determined to have been caused by the user.Actions taken to mitigate the reported issue: no actions were taken.Additional information provided in b1, b5, d10, g4, h3, h6.

• Brand Name: SILICONE - BIVONA TUBES CUSTOM TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8575275
• Report Number: 3012307300-2019-02415
• Device Sequence Number: 2494873
• Product Code: JOH
• UDI-Device Identifier: 15019517093292
• UDI-Public: 15019517093292
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 150195170932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: Lay User/Patient
• Device Expiration Date: 02/27/2024
• Device Model Number: FT17AN40NGE057N
• Device Catalogue Number: FT17AN40NGE057N
• Device Lot Number: DS024696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic