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

Model Number 670180

Device Problems Leak/Splash (1354); Unintended Deflation (4061)

Patient Problems Ventilator Dependent (2395); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

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 water was leaking slowly from the opening of pilot balloon and the cuff did not remain inflated after 2-3 days of use.After removal, the water inside cuff decreased.Pre-existing conditions, mechanically ventilated.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Device evaluation: one device was returned for investigation.Visual inspection found no unusual condition was detected in the sample.Functional testing of the sample showed it inflated without problems and remained inflated.The complaint was not confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective actions are required since the complaint was not confirmed.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17191269
• MDR Text Key: 317760834
• Report Number: 3012307300-2023-06583
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006070
• UDI-Public: 15021312006070
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 670180
• Device Catalogue Number: 670180
• Device Lot Number: 4267580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Race: Asian