MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEO/PED TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	60SN025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.A dhr review was unable to be performed as no lot information was provided.
Event or Problem Description
It was reported that the trach had broken at the flange/tube while the patient was at home.The trach was in the pt when it broke.The trach had not been in use for very long.It was being cleaned as per manufacturers recommendation.The patient has had this size trach for some time and has not had issues with other trachs.The issue was resolved by swapping out the trach.There was no patient injury reported.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).Additional information: pictures were returned.Five pictures were attached and reviewed.Pictures 2 and 3 show an uncuffed tube, pictures 1, 4, and 5 show the trach shaft unattached and held by a wire.Functional testing could not be performed as no product was returned for analysis.The pictures sent does not clearly show how the reported failure could've occurred, and no lot information was provided for device history review.The root cause could not be confirmed.

• Brand Name: BIVONA UNCUFFED NEO/PED TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14014244
• Report Number: 3012307300-2022-05834
• Device Sequence Number: 17710718
• Product Code: BTO
• UDI-Device Identifier: 15021312000115
• UDI-Public: 15021312000115
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 60SN025
• Device Catalogue Number: 60SN025
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 5 YR
• Patient Sex: Male