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

Catalog Number 7551707

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

Event Description

It was reported three tracheotomy cannulas with the same lot number presented an issue where the balloons would deflate approximately 7 to 20 days after use.The nurse sometimes needed to re- inflate every hour.There were no reported consequences to health observed for the patient.Only discomfort for the patient was noted.

Manufacturer Narrative

Evaluation summary: visual inspection of the returned device was performed by the unaided eye under normal plant lighting and did not reveal any anomalies.Using a standard syringe, 20 ml of air was inserted into the inflation line; the cuff fully inflated.Following work instruction, (b)(4), the device was leak tested and no leaks were observed.The instruction for use, (b)(4) , states: "4.3 use either minimal leak or minimal occlusive volume techniques to establish the cuff and to ensure correct inflation at regular intervals".Silicone cuffs are permeable to air and therefore, subject to slow, spontaneous deflation and require monitoring at regular intervals.The cuffs are not designed to hold air for 7 to 20 days without adjustment.Lot 3178731 for 17 units was released for distribution on 25-apr-2016; there were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the dhr.Based on these results, this investigation did not confirm the complaint or reveal any intrinsic manufacturing defects with the returned device.No corrective actions are planned at this time.Smiths medical regularly analyzes complaint data and trends, and will take further actions accordingly.

• Brand Name: BIVONA TRACHEOSTOMY TUBE
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue,; gary IN 46406
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7626556
• MDR Text Key: 112185916
• Report Number: 3012307300-2018-02485
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006476
• UDI-Public: 15021312006476
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K914088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/07/2021
• Device Catalogue Number: 7551707
• Device Lot Number: 3178731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1