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

Catalog Number	ZT23BN60NSB029N
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while cleaning the inside of the cuff there appeared to be growing mold.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
One device was returned for evaluation.Visual inspection under normal plant lighting confirmed that there was black contamination under the cuffs and inside the inflation balloons.It is likely the fluid being introduced into the inflation system and/or the syringe that is being used to convey the fluid is not sterile.Also, the cleanliness of syringe could have contributed to the foreign matter on device.The investigation did not determine a manufacturing defect with the returned sample.The dhr was reviewed and found the devices were assembled by different operators and all the components and bench materials were from different lot numbers except for the wire in the shaft.

• Brand Name: BIVONA CUSTOM FLEXTEND TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19697402
• Report Number: 1824231-2024-00059
• Device Sequence Number: 20621890
• Product Code: JOH
• UDI-Device Identifier: 15019517333473
• UDI-Public: (01)15019517333473(17)290312(10)GB018252
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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 Catalogue Number: ZT23BN60NSB029N
• Device Lot Number: GB018252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Unknown
• Patient Race: White