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

Catalog Number	75HA70
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.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.
Event or Problem Description
It was reported that the device was removed from the box and ready to be used, the cuff cannot be removed totally from the cannula body.The device was ready to be used on the patient, but it was not possible to proceed.There was no patient involvement, no harm/adverse event reported.
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: received one decontaminated 7.0 aire cuf trach tube adjustable hyperflex for evaluation.Visual inspection by the unaided eye under normal plant lighting was performed on the returned device.The sample appeared to have not been used.The cuff was inflated with 10cc of air and visual inspection confirmed the cuff was pinched (i.E., stuck to itself) in one area.The air was removed, and the cuff deflated to its natural state.Following normal cuff manipulation practices, the pinched area was released.The cuff was inflated and deflated multiple times without issue.The cuff remained free and unstuck to itself.The pinched area may have been the result of teflon spray being absent in that area, excessive teflon drying in that area, or the storage conditions of the device.Silicone has the propensity to stick to itself over time.With manipulation, the bond releases and the silicone cuff continues to function as designed.This is not considered a manufacturing defect.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 TRACHEOSTOMY TUBE, ADULT HYPERFLEX
• 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: 19497966
• Report Number: 1824231-2024-00051
• Device Sequence Number: 6661659
• Product Code: JOH
• UDI-Device Identifier: 15021312013849
• UDI-Public: (01)15021312013849(17)271201(10)4351158
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 75HA70
• Device Lot Number: 4351158
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2022
• 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