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

Model Number	SZ20FN60NSZ007S
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|silicone - bivona tubes custom was leaking reported trachs are looking different than before and the cuffs are not holding water like they used to as for having to add more water and work harder to keep air out.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol b10010116, as a result of warning letter (b)(4).Additional information provided in h3, h6, and h10.A device history record (dhr) review of the reported lot was conducted which indicated all inspections were completed and no issues were noted during manufacture.A sample device was returned for evaluation.Visual inspection of the returned device determined that device did not match the provided part number or lot number.The returned device was assembled with white-colored silicone, which is used for standard product.The dhr identified components that were made with clear-colored silicone, which are used on custom products.The returned device was made with a 5.5 id shaft and the identified part number was made with a 6.0 id shaft per the dhr.Visual inspection confirmed a ruptured cuff, but it also confirmed that the product was beyond the 5-year shelf life stated on the labeling for the product.Root cause could not be determined and no corrective action was performed.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11952926
• Report Number: 3012307300-2021-05699
• Device Sequence Number: 14456907
• Product Code: JOH
• UDI-Device Identifier: 15019517230871
• UDI-Public: 15019517230871
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: SZ20FN60NSZ007S
• Device Catalogue Number: SZ20FN60NSZ007S
• Device Lot Number: BS007713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown