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

Model Number 670180

Device Problem Leak/Splash (1354)

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

Event Date 11/25/2022

Event Type  Injury  

Event Description

It was reported that the device has a cuff leakage.The customer confirmed the outcome of the event that they replaced it with a new device.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

H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual inspection found a rip was detected in sample; therefore, air cuff leak was detected.No other analysis was performed.An internal capa was opened on january 5th, 2022, to address root cause investigation for leakage issues.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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; jianguo n. road; minneapolis, MN 55442
• MDR Report Key: 16010361
• MDR Text Key: 305776616
• Report Number: 3012307300-2022-27962
• 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: 03/28/2023

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
• Device Operator: Health Professional
• Device Model Number: 670180
• Device Catalogue Number: 670180
• Device Lot Number: 4280800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 02/12/2023
• Supplement Dates FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian