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

Catalog Number	67HA80
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 reporter phone is (b)(6).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 cuff leaked after 14 days of use and was resolved by replacing with a new kit.No patient injury or clinical affects was reported.
Additional Manufacturer Narrative
H3 and h6 - evaluation codes: updated.Device evaluation: one used unit was received.The trach, an obturator and a 12 ml syringe were returned.Visual inspection of the returned devices using the naked eye and under normal plant lighting confirmed the device had been used.There was noticeable discoloration of the adjustable neck flange.Functional testing discovered a leak was detected in the cuff approximately 37 mm from the distal tip and 6 mm away from the inflation line on the underside of the shaft (opposite side of the printed graduation marks).There appeared to be light score marks on the cuff near the location of the leak.Using magnification, there were two spots among the score marks; one spot propagated into a hole the other was still intact.The indications for use states that this device is not intended for long-term use.This tube provides temporary airway access for a tracheotomized patient when determining the optimal tube length for a patient.This tube must be replaced with a fixed neck flange tracheostomy tube when the optimal length is determined.There are no cleaning or reprocessing instruction for an adjustable hyperflex.The discoloring of the device indicates that the device may have been used for long term.The score marks on the cuff may be contributed by a rough spot or splinter in the trachea or if the device was reprocessed, by scrubbing the cuff with a sharp implement or brush.Likely root cause is use inconsistent with the ifu or the device coming in contact with a sharp object.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.No actions taken.B1, b2, h1 and h6 - health impact codes.

• Brand Name: BIVONA TUBES ADULT HYPERFLEX TTS
• 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: 18359985
• Report Number: 1824231-2023-00002
• Device Sequence Number: 8014724
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: (01)15021312013818(17)270916(10)4321573
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 67HA80
• Device Lot Number: 4321573
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown