MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67HA80
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hyperventilation (1910)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that bivona® adult tts¿ adjustable neck flange hyperflex¿ tracheostomy tube had a cuff leak after 5 days of use.The patient was panting as a result of this incident.The patient changed out the trach tube, and was reported to be in stable condition after this.No further complication were reported.
Additional Manufacturer Narrative
Visual inspection was performed with the unaided eye under normal plant lighting.A tiny puncture was noticed on the cuff on the underside of the shaft approximately 20 mm from the proximal cuff band (reference pictures).Using the dinolight to magnify the area, the tear appeared to have been the result of the cuff coming in contact with a sharp edge or object either prior to use, while reprocessing, or when in situ.The instruction for use, pkg-dfu-hta-2 rev 001, states under warnings to guard against product damage by avoiding contact with sharp edges.The ifu also states under indications for use 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.A dhr review was unable to be performed since an incorrect lot number was provided.The potential lot number 3413511 identified in the complaint does not match the returned product.Lot 3413511 for 58 units of part number 670170 was released on 19-may-2017 for distribution.The returned product is a 67ha80.

• Brand Name: BIVONA® ADULT TTS¿ ADJUSTABLE NECK FLANGE HYPERFLEX¿
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue,; gary IN 46406
• Manufacturer Contact: jim halverson ; 6000 nathan ln n; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7716019
• Report Number: 3012307300-2018-02802
• Device Sequence Number: 1107771
• Product Code: JOH
• UDI-Device Identifier: 15021312013818
• UDI-Public: 15021312013818
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: Lay User/Patient
• Device Model Number: 67HA80
• Device Catalogue Number: 67HA806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 04/21/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown