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

Catalog Number	67PFS35
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during patient use, the silicone broke off of the plastic at the hub.A trach change out was performed as a result.No further complications were reported in relation to this event.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Visual inspection found the device to have a broken connector, and wrinkles in the cuff.As functional testing, 32 assemblies taken out of production floor inventory were reviewed to see if they had adhesive curing issue; no adhesive issues were detected on the units.The reported customer complaint was not confirmed.The most probably cause of issue been determined to be that damage occurred after product left shm facilities.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8724504
• Report Number: 3012307300-2019-03629
• Device Sequence Number: 1787832
• Product Code: JOH
• UDI-Device Identifier: 10351688518613
• UDI-Public: 10351688518613
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 67PFS35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention