MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TIGHT TO SHAFT NEO V NECK FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67N040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a balloon failure in the bivona trach tube where the cuff only inflated on one side.This happened during the patient's trach change.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
Unknown manufacturer: a catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, (b)(6) has been listed in sections d3.And g1.And the (b)(6) fda registration number has been used for the manufacture report number.D4.Lot number, expiration date, udi, and h4.Manufacture date are unknown; no information has been provided to date.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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
The following field was updated with additional information: a2.Age at time of event: 7 a2.Age units (patient): months a4.Weight: 7.4 a4.Weight units (patient): kg a6.Race: black or african american d1.Brand name: bivona tight to shaft neo v neck flange tracheostomy tube d3.Manufacturing plant name: smiths healthcare manufacturing s.A.De c.V.D3.Manufacturing plant address 1: ave calidad no.4, parque d3.Manufacturing plant city: tijuana d3.Zip code: (b)(4) d3.Manufacturing plant state: na d3.Manufacturing plant country: mex d4.Catalog #: 67n040 d4.Primary udi number: (b)(4).D9.Date returned to mfg: 31-may-2024 g4.Pma/510(k) #: na h6.Investigation codes: updated.Investigation summary: the sample returned consisted of one (1) for p/n: 67n040 in used condition, in a plastic bag.During the visual inspection it was detected that the cuff was stuck to the tube but after massaging the cuff unstuck and inflated correctly.Symmetry measurement was performed to confirm if the value is less than 33% established in the bivona tt-fg-tj qp.The symmetry value was 40% (8/20*100).The sample worked as expected and the failure modes reported by the customer were not confirmed.No root cause could be determined.A device history record could not be completed as no lot number was received.

• Brand Name: BIVONA TIGHT TO SHAFT NEO V NECK FLANGE TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana MN ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19238072
• Report Number: 3012307300-2024-03355
• Device Sequence Number: 20845268
• Product Code: JOH
• UDI-Device Identifier: 15021312006230
• UDI-Public: (01)15021312006230
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 67N040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/01/2024
• 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: 7 MO
• Patient Sex: Unknown
• Patient Weight: 7 KG
• Patient Race: Black Or African American