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

Model Number 670170

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  Injury  

Event Description

It was reported that there was leakage after thirteen (13) days in use.Device was replaced with another trach.No injury reported.

Manufacturer Narrative

A product sample was received and is awaiting evaluation and 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.

Manufacturer Narrative

Other, other text: h3.Device evaluated by manufacturer and h6.Event problem and evaluation codes: updated.One sample was received in used conditions without original package.The device was visually inspected under normal conditions of illumination and filled with 5cc of air according to check for any functional problems.A hole was detected in the cuff and a leak occurred confirming the customer complaint.This issue was escalated to an internal capa and occurrence is being monitored via trend analysis.If the occurrence of this issue increases significantly, additional corrective actions will be taken.A device history record (dhr) reviewed showed that no issues or non-conformances reported during the manufacture of the reported lot.

• Brand Name: BIVONA TUBES ADULT TTS
• Type of Device: 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: 16055434
• MDR Text Key: 306209359
• Report Number: 3012307300-2022-28184
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 670170
• Device Catalogue Number: 670170
• Device Lot Number: 4267577
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/14/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/27/2022
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian