MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES ADULT AIRE-CUF; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	750180
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received.Three photos and two videos were received.According to the images it is observed the cuff can inflated, however a part of the cuff is adhered to each other.The was confirmed for cuff sticking.A root cause could not be identified as the product was not received.A device history record (dhr) review reported no discrepancies or non-conformance's during the manufacturing of the reported lot number.
Event or Problem Description
It was reported that the cuff was adhered and couldn't be fully inflated during pre-test.The user followed the ifu (instructions for use) and tried to remove the adhesion by massaging the cuff but was in vain.They then opened a new one but was also having the same problem.Replaced with third device.The event occurred during pre-test; no patient was involved or harmed.One patient, two product malfunctions.Emdr (b)(4) and emdr (b)(4) both represent the same patient.This is the first malfunction report for the related complaints.

• Brand Name: BIVONA TUBES ADULT AIRE-CUF
• 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: 19911934
• Report Number: 1824231-2024-00070
• Device Sequence Number: 18311271
• Product Code: JOH
• UDI-Device Identifier: 15021312006421
• UDI-Public: (01)15021312006421(17)270512(10)4255460
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2024

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: Other
• Device Catalogue Number: 750180
• Device Lot Number: 4255460
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown