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

Catalog Number	67PFSS50
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 spring was breaking through exterior of trach.There was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: no sample was received from the customer.Six photos were attached for the evaluation.On review of the photos, cuts, tears and wear were identified on the surface of the tube, causing exposure of the tube wire.No information was provided on how many times the product was used and how the sanitization process was done.One sample of our inventory was taken to try to replicate the failure mode.The sample was pulled from the connector with force, the whole assembly and adhesive stayed attached to the connector.It was not possible to break the tube.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause is that damage occurred after the product left the facility.A retrospective review of 12-month period was made for complaints originated and related to this issue and no additional complaints were identified to this lot.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Additional Manufacturer Narrative
D4 - expiration date; d4 - primary udi number and h4 - device mfg date: correction.D9: 12/10/2024.H6: updated.H3: six photos and two samples were provided for evaluation.During the visual inspection of the returned samples, a cut in the tube was identified, which causes the wire to be exposed in both samples.The cut is located near the joint of the tube and the connector.In addition, additional wear can be seen in the damage zone.The failure mode was able to be confirmed.After a review of the different verifications that are performed during the manufacturing process to detect damaged components, the most probable root cause is that damage occurred after the product left the facility.The part returned has a cut in the tube, per instructions for use (ifu) can be re-processed in a patient up to 5 times and time of use up to 29 days.No information was provided of how many times the product was used and how the sanitization process was made for the part.A retrospective review of 12-month period was made for complaints originated related to this issue and no additional complaints were identified to this part number and lot.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• 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: 20268460
• Report Number: 9617604-2024-00738
• Device Sequence Number: 7418887
• Product Code: JOH
• UDI-Device Identifier: 10351688518712
• UDI-Public: (01)10351688518712(17)290512(10)6017584
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 67PFSS50
• Device Lot Number: 6017584
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 04/17/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/18/2024; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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: 6 YR
• Patient Sex: Unknown
• Patient Race: White