MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM TRACHEOSTOMY TUBE, ADULT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	SU22CN40NGF005S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that a patient has a custom trach where the flange on the side has broken twice in a month.The issue happened on separate occasions causing the trach to dislodge.It is unknown how the issue was resolved at this time.No patient injury or adverse affects have been reported.
Additional Manufacturer Narrative
Other, other text: two (2) photos were provided for evaluation.Review of the provided pictures confirmed a torn eyelet.No information was provided as to the type of tracheostomy holder used.Based on the pictures, it appears one with velcro and/or metal clips.Section 4.0 warnings in the (ifu) instructions for use says, 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.We recommend using the twill tape holder supplied with the product.The reinforced eyelets are more robust, but are still made out of silicone, which can be cut by velcro or metal clips.No corrective actions are planned at this time.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.

• Brand Name: BIVONA CUSTOM TRACHEOSTOMY TUBE, ADULT
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15321651
• Report Number: 3012307300-2022-16798
• Device Sequence Number: 14760010
• Product Code: JOH
• UDI-Device Identifier: 15019517300352
• UDI-Public: 15019517300352
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2022

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: Health Professional
• Device Model Number: SU22CN40NGF005S
• Device Catalogue Number: SU22CN40NGF005S
• Device Lot Number: GA028915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown