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

Model Number 670175

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

The reported lot number is assumed but not confirmed.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.

Event Description

It was reported that a trach had a cuff leak that was discovered while in use for twelve (12) days with a patient.Leakage was confirmed when the product was withdrawn from the patient and further tested.No injury was reported.

Manufacturer Narrative

One device and two photos were received for investigation.The device was visually inspected and was detected that the cuff of the trachel tube had a tear.A leak test was performed and the device failed the test.The complaint is confirmed.According to the customer's report, the product was found damaged until its use, during the pre-check no leakage was reported on the cuff according with the instructions for use, and it was until it was withdraw from patient after 12 days when it leaked, the root cause could be due to improper use of the product.A review of the device of the device history records could not be completed as the lot number provided by the customer was incorrect.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, ADULT
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16677971
• MDR Text Key: 312685918
• Report Number: 3012307300-2023-03520
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006063
• UDI-Public: 15021312006063
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 670175
• Device Catalogue Number: 670175
• Device Lot Number: 4257599
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian