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

Catalog Number 670185

Device Problem Leak/Splash (1354)

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

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

D5.Other operator of device: operator of device is unknown.E3.Initial reporter occupation: product specialist 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 the tracheostomy tube was placed and leaked after 2 days of use.This problem was solved by replacing it with a new trach tube.There was patient involvement and no patient harm/adverse event reported.This complaint was created to capture the 2nd of 2 related incidents.

Manufacturer Narrative

Additional information: h4: manufacture date.H3.& h6.Investigation codes: updated.Investigation summary: one used unit was received in a used plastic bag and decontaminated for evaluation.During visual inspection no defects were detected in the sample.The sample was inflated with the use of a syringe and submerged under water to detect the reported condition, and a leak in the cuff was identified, confirming the customer's indicated failure.A capa was opened to address the root cause of cuffed products not inflating symmetrically or maintaining inflation and leaking.Lot: 4137672 for (b)(4) units was released on 21 may 2021.There was no ncmr or scrap initiated for the lot.H6.Component code: g04038 cuff.

• Brand Name: BIVONA TTS TRACHEOSTOMY TUBE ADULT TIGHT TO SHAFT
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18702565
• MDR Text Key: 335354577
• Report Number: 1824231-2024-00010
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 670185
• Device Lot Number: 4137672
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention