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

Catalog Number	67PFPS60
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the device would not fully inflate.There was no patient involvement or patient harm/adverse event.
Additional Manufacturer Narrative
Investigation summary: the affected device was not returned for evaluation.Two photographs were provided for evaluation.As per photos provided by the customer, it was identified that the cuff did not inflate completely and a part of it remains stuck to the tube.The cuff issue was confirmed.As per instructions for use 10018859-001 section set up and use ¿attach a syringe to the pilot balloon and slowly inflate the cuff with 5ml of sterile water.If the cuff does not inflate completely, squeeze the pilot balloon while gently manipulating the cuff from the shaft¿.The customer did not specify if they followed the instructions.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.Capa-000862 was opened on january 5th, 2022, to address root cause investigation for bivona silicone cuffed products do not inflate symmetrically, do not maintain inflation.Capa is currently in investigation phase.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19752459
• Report Number: 3012307300-2024-06181
• Device Sequence Number: 13015805
• Product Code: JOH
• UDI-Device Identifier: 10351688518583
• UDI-Public: (01)10351688518583(17)280412(10)4380996
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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: 67PFPS60
• Device Lot Number: 4380996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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