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	Malfunction
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
One tracheostomy was returned for evaluation.Device was made with the 4c neck flange, an adult straight neck flange (83 mm ).The neck flange type selected by the clinician was the 4c neck flange.The ordering history for part number (b)(4) revealed that there has only been one lot produced.A query of the patient's name in the custom lab database did not reveal any other customized part numbers.Based on the template's specifications (3.0 mm id, 25 mm proximal length and 39 mm distal length) and the information provided in the complaint description, it is hypothesized that the complainant previously used a standard stock product, 60pfs30.The standard product is built with a v-shaped neck flange and has a 3.0 mm id, 20 mm proximal length and 39 distal length.If the customer wants the v-shaped neck flange on a shaft that is built with a 25 mm proximal length and 39 distal length, a new template will need to be provided by the clinician identifying the 4a neck flange.No corrective actions are planned at this time.

• 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
• MDR Report Key: 8575364
• Report Number: 3012307300-2019-02414
• Device Sequence Number: 284875
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: No Information
• 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: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR