MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60P055
Medical Device Problem Codes	Structural Problem (2506); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.E2 - incorrect due to system limitations.Initial reporter is strategic purchasing and product manager.H3 - other: device has not been returned to date.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 stated that a "wire was coming out of both the one and the other cannula".The event date, lot number and patient involvement are unknown.No harm has been reported.The product will be available for investigation after the distributor will receive it.
Additional Manufacturer Narrative
D9: date returned to mfg.: 3/11/2024.B5, d4, d5, h3, h4, h6.Health effects and evaluation codes: updated.Two device samples were received in used condition, in a plastic bag.During visual inspection it was identify a broken cuff, no exposed wire was identified in the samples.The failure mode of ¿guidewire problem¿ was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken since the reported failure was not confirmed.
Event or Problem Description
Additional information was received via email clarifying that there are two products that need to be investigated.The event occurred after preparation with the vaporizer.The operator of the device was a care giver.There was patient involvement, and no patient harm/adverse event was reported.No medical intervention was required.The event date is unknown.No further information is available.
Additional Manufacturer Narrative
H2) correction: h3, h6: two device samples were received in used condition, in a plastic bag.However, both samples returned were part number 67p055 which is different from the reported and correct part number that the customer provided which was 60p055.Additionally, the exposed wire for 60p055 is cuffless, and the item number from the returned samples received for investigation was 67p055 which is a cuff device.When additional information becomes available if the correct samples are still available then a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56.

• Brand Name: BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18530084
• Report Number: 9617604-2024-00058
• Device Sequence Number: 7587836
• Product Code: BTO
• UDI-Device Identifier: 15021312005783
• UDI-Public: (01)15021312005783(17)280222(10)4374483
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2025

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: 60P055
• Device Lot Number: 4374483
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 03/12/2024; 02/26/2025
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 04/09/2024; 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2023
• 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