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

Model Number	HT15BS60NSC083S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer stated the damaged trach has a cuff that is leaking water when inflated.This is a custom trach, with the tight-to-shaft cuff added on.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
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 additional reportable information becomes available.
Additional Manufacturer Narrative
Other, other text: h6.Evaluation codes: updated.No product sample was returned for investigation.One photograph of the device was received for analysis.Upon magnification, abrasions were visible on the device cuff in the image, however, the investigation could not identify a source of leakage from the image, therefore the complaint could not be confirmed.Review of manufacturing device history records found no non-conformances or anomalies that could result in the reported issue.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: BIVONA TUBES CUSTOM
• 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: 16104224
• Report Number: 3012307300-2023-00155
• Device Sequence Number: 12676077
• Product Code: JOH
• UDI-Device Identifier: 10351688840486
• UDI-Public: 10351688840486
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2023

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 Expiration Date: 12/20/2021
• Device Model Number: HT15BS60NSC083S
• Device Catalogue Number: HT15BS60NSC083S
• Device Lot Number: GS032707
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2016
• 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