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

Model Number 67N035

Device Problems Inflation Problem (1310); Leak/Splash (1354); Naturally Worn (2988)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms#: (b)(4).No problems or issues were identified during the device history record review.3 samples and 3 pictures were received.Sample 1: during the test, leaks were found in the cuff.It was observed the cuff surface was worn with areas with stretch marks.The holes were in the worn areas.The complaint is confirmed.Based on the tests performed to replicate the failure mode, where it could not be reproduced using the tools from assembly process, the most probable root cause is that damage occurred after the product left manufacturing facilities.Sample 2 and 3: when the samples were inflated with air, the cuff only inflated one side.The pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.Root cause could not be determined with the provided information.No corrective actions were taken since the complaint was not confirmed.

Event Description

It was reported that two cuffs were not inflating and one cuff was leaking.No patient injury was reported.

• Brand Name: BIVONA TUBES TRACHEOSTOMY
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16475478
• MDR Text Key: 310590788
• Report Number: 3012307300-2023-01961
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006223
• UDI-Public: 15021312006223
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2023

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: 67N035
• Device Catalogue Number: 67N035
• Device Lot Number: 3868245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1