MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SP030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.No images were provided.Three (3) samples were received without their original packaging inside a ziploc bag, in used conditions and with their certificate of safe handling.Visual inspection was performed at 12 inches under normal lighting to received units, in order to detect any damage on the cuff, airline or pilot balloon.No damaged could be detected.Functional test: samples were filled with 5 cubic centime (cc) of air according to procedures in order to see if there was any functional problem.When inflated the sample 1 with air, the pilot balloon inflated completely.Sample 1: after the whole cuff inflated, the technician deflated and inflated 4 times, all the times the cuff inflated completely.Therefore can conclude failure mode reported wasn?t confirmed.Sample 2: when inflated the sample 2 with air, the pilot balloon inflated completely.After the whole cuff inflated, the technician deflated and inflated 4 times, all the times the cuff inflated completely.Therefore, can conclude failure mode reported wasn't confirmed.Sample 3: when inflated the sample 1 with air, the pilot balloon inflated but all air was stuck it.According to the information for use, the technician manipulated the pilot balloon and the cuff inflated but only one side, the technician manipulated the cuff and the whole cuff inflated.After the whole cuff inflated, the technician deflated and inflated 4 times, all the times the cuff inflated completely.Therefore, can conclude failure mode reported wasn?t confirmed.The samples were tested on leak test.The test was performed under water as per procedures the technician inflated the unit, and visually inspected the sample for 10 seconds, did not observe any leakage.Then submerged the units under water, did not observe any leakage.The technician did not detect leaks during the test.The complaint is not confirmed.The root cause of the reported issue was not confirmed.No corrective actions were taken since the complaint was not confirmed.
Event or Problem Description
It was reported while preparing the trach tube for insertion, it was discovered that the cuff of 3 trachs were not inflating.A new trach was received from intensive care unit (icu) to place in the patient.No patient injury was reported.Additional information received 20 may 2021 fourth trach has failed during pre-test.

• Brand Name: BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16376578
• Report Number: 3012307300-2023-01268
• Device Sequence Number: 17724017
• Product Code: JOH
• UDI-Device Identifier: 15021312000696
• UDI-Public: 15021312000696
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

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 Expiration Date: 02/06/2025
• Device Model Number: 67SP030
• Device Catalogue Number: 67SP030
• Device Lot Number: 3942489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/14/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Sex: Male
• Patient Weight: 6 KG