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

Model Number	XU21DS60NSC940N
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes custom plastic sheath around wire was torn while in use with the patient.Customer is requesting replacements.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Dhr review was done, no issues related to the original complaint were found.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4) although a specific lot number was not provided, based on information provided by the complainant, it was determined that st004080 or st004368 were possible lots where the returned device originated.The device history report( dhrs) for these lots were reviewed and no non-conformances, discrepancies, or rework that would be considered related to this issue were noted.A product sample was received for evaluation.Visual and functional testing were performed.One device was received by the manufacturing site for investigation.Based on information provided by the complainant, it was confirmed to have been the manufacturing site-assembled part.Immediately upon observing the device, it was apparent that there was a small slit in the shaft between the connector and the neckflange.It was also noted that this same customer previously made a complaint for a similar issue involving a different device.Based on the photos provided for that other complaint, it appears there is a slit present in the same general area of the device.The root cause of the reported issue could not be confirmed as the reported issue could not be determined.No actions were taken to mitigate the reported issue.

• Brand Name: BIVONA TUBES CUSTOM
• 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): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 12338308
• Report Number: 3012307300-2021-08581
• Device Sequence Number: 15355871
• Product Code: JOH
• UDI-Device Identifier: 15019517265224
• UDI-Public: 15019517265224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: XU21DS60NSC940N
• Device Catalogue Number: XU21DS60NSC940N
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 01/10/2022; 12/19/2022
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 02/08/2022; 01/19/2023
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown