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

Catalog Number	67HA60
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when trach was opened and inserted, it was found that the balloon had been cut off the trach.Trach was removed and backup inserted.There was medical intervention required.There was patient involvement, and no patient event reported.
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 reportable information becomes available.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.Visual inspection by the unaided eye under normal plant lighting revealed that there was a stain / discoloration on the connector above where one of the obturator prongs would secure to the connector.The length of the airway line on a clear, over molded airway balloon is 225 mm +/- 10 mm.Based on the length of the airway line the investigation determined that it was unlikely that the airway line was cut but may have been stretched.Passing the airway line between two fingers revealed a slight kink approximately 30 mm from the tip of the air way.The kink may have been caused by the airway line becoming trapped, which resulted in a pull force applied to the airway line which caused it to pull out of the balloon.Visual inspection of the balloon opening where the airway line is inserted and the end of the airway line that gets over molded did not reveal torn or jagged surfaces.There were no short shots or obvious molding defects observable.A pull test is performed on the first shot (8 parts) of the over molded inflation balloons using method 50.The pull test requirement is to meet or exceed 1.0 lbf.The pull test record was reviewed for over-molded balloon subassembly.The investigation confirmed that the airway line separated from the balloon, but the root cause of the incident was unable to be determined.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.

• Brand Name: BIVONA HYPERFLEX 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20185209
• Report Number: 1824231-2024-00084
• Device Sequence Number: 8722656
• Product Code: JOH
• UDI-Device Identifier: 15021312013795
• UDI-Public: (01)15021312013795(17)290205(10)4454369
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081440
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 67HA60
• Device Lot Number: 4454369
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/07/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 13 MO
• Patient Sex: Male
• Patient Weight: 12 KG
• Patient Ethnicity: Hispanic
• Patient Race: White