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

Catalog Number 67PFPS60

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Event Description

It was reported that the tracheostomy was used twice for a total of 52 days.The operator noted that the syringe pulled the air valve such that the cuff could no longer be inflated.An emergency tracheostomy change was performed as a result.The patient was closely monitored for aspiration.No patient injury or further complications were reported in relation to this event.

• Brand Name: BIVONA
• 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; 3350 granada avenue north; suite 100; oakdale MN 55128
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9303029
• MDR Text Key: 165814407
• Report Number: 3012307300-2019-05788
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518583
• UDI-Public: 10351688518583
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 67PFPS60
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR