MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SILICONE - BIVONA TUBES ADULT TTS; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	670175
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No lot or serial numbers were communicated; device expiration date and device manufacturing date not available.Device evaluation 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.
Event or Problem Description
It was reported the health professional had difficulty injecting and withdrawing water from cuff.The event occur at homecare clinic.No patient injury was reported.Additional information received via customer response email 9-nov-2022 : no medical intervention.The outcome of the event was resolved.
Additional Manufacturer Narrative
H6: event problem and evaluation codes: updated.Device evaluation: two (2) pictures were attached and reviewed.Picture one showed tracheostomy tube inside its original tray.Picture two showed tracheostomy tube inside a bag with the cuff inflated.The reported failure mode was not confirmed.No product was returned for analysis.No root cause could be determined from the pictures submitted.No corrective actions were performed since the root cause cannot be determined from the pictures provided.No fault was found.If the product is returned, the manufacturer will reopen this complaint for further investigation.No lot or serial number was provided therefore, a device history record dhr review could not be performed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.

• Brand Name: SILICONE - BIVONA TUBES ADULT TTS
• 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: 15808530
• Report Number: 3012307300-2022-27270
• Device Sequence Number: 5747350
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: 15021312006063
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: 670175
• Device Catalogue Number: 670175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2022
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 04/27/2023
• 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 Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian