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

Model Number	FT22AN40NGE999N
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff was busted and leaking.No additional information.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated h10: device evaluation: the device was returned for investigation.The returned product was reviewed and found to have a large hole in the cuff which was immediately confirmed to prohibit the cuff from being inflated.Custom devices are 200% leaked tested prior to packaging, which requires the cuffs to be inflated and deflated.Per the complaint description, it was implied that the devices operated appropriately prior to the cuff becoming damaged (i.E.The customer says that this was noted during testing before a routine trach change).It is unknown what caused the cuff to become damaged, however it is highly unlikely to have become damaged prior to leaving the manufacturing facility due to the reasons explained above.Based on this finding, no corrections or corrective actions are planned at this time.Icu medical routinely monitors post-market data for additional information and trends, which could lead to further action being deemed appropriate in the future.The dhr specified by the customer (st009830) was reviewed.No discrepancies or non-conformances were noted for this lot number.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14135554
• Report Number: 3012307300-2022-06506
• Device Sequence Number: 11797879
• Product Code: JOH
• UDI-Device Identifier: 15019517291162
• UDI-Public: 15019517291162
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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 Model Number: FT22AN40NGE999N
• Device Catalogue Number: FT22AN40NGE999N
• Device Lot Number: ST009830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown