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

Model Number 67SP040

Device Problem Product Quality Problem (1506)

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

Event Date 08/02/2020

Event Type  malfunction  

Manufacturer Narrative

Operator of device is patient/consumer.Initial reporter also sent report to fda is unknown.No information has been provided to date.No dhr review was performed.A product sample was received for evaluation.Visual and functional testing were performed.Sample 1, the cuff wasn't inflating uniformly.The root cause of the reported issue was found to be cuff symmetry test of representative sample per lot by quality inspectors.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Event Description

It was reported that cuff would not inflate and the water would not go down the cuff.No patient injury was reported.

• Brand Name: BIVONA
• 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: 15468979
• MDR Text Key: 302187860
• Report Number: 3012307300-2022-20161
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312000726
• UDI-Public: 15021312000726
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2022

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: 67SP040
• Device Catalogue Number: 67SP040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2022
• Initial Date FDA Received: 09/22/2022
• 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