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

Catalog Number 67NFPS35

Device Problems Infusion or Flow Problem (2964); Incomplete or Inadequate Connection (4037)

Patient Problem No Information (3190)

Event Date 06/05/2018

Event Type  Injury  

Event Description

Information was received that cuff does not inflate the whole way around a smiths medical tracheostomy, despite putting larger amounts of water in the cuff.It was reported that patient was unable to be ventilated as a result of the large air leak.A new tracheostomy tube was placed to provide oxygenation.

Manufacturer Narrative

Device evaluation: one bivona tracheostomy sample was received in used condition without its original packaging for evaluation.The sample was visually inspected and no discrepancies were found.A leak test was performed and when inflating the unit with air, it was seen that the cuff inflated, but a part was not uniformly.The cuff was then manipulated and the whole cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.Then air cuff symmetry test was performed and the percentage result was found to be over the minimum acceptable, but the unit was still found to be within specification.To further investigate the issue, documents were reviewed and deemed adequate.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.Air cuff symmetry tests were also audited during thirty two (32) units finding no discrepancies.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and testing, the complaint was not confirmed.

• Brand Name: SMITHS MEDICAL BIVONA TUBES NEO/PED FLEXTEND
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8794585
• MDR Text Key: 151175163
• Report Number: 3012307300-2019-03539
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518798
• UDI-Public: 10351688518798
• Combination Product (y/n): N
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/18/2024
• Device Catalogue Number: 67NFPS35
• Device Lot Number: 3744780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 MO
• Patient Weight: 7