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

Catalog Number	67PFS45
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: 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.
Event or Problem Description
It was reported that the cuff was defective and did not completely encircle the tube/stuck to one side of the tube.The issue was discovered prior to patient use.The event occurred during testing of the cuff.There was no harm/adverse event reported.
Additional Manufacturer Narrative
D9.Date returned to mfg: 27-nov-2024.H6.Investigation codes: updated.Investigation summary: investigation summary: received two (2) new list# 67pfs45 pediatric tracheostomy tube.As received, no damage or anomalies were observed.For each set, a syringe was attached to the pilot balloon and slowly inflated with 5ml of sterile water.Both sets were observed to not inflate.Each set was manipulated per ifu (instructions for use) until the cuff inflated.The complaint of defective cuff not completely encircling the tube can be confirmed.However, after massaging the cuff the issue was resolved.The ifu states: "if the cuff does not inflate completely, squeeze the pilot balloon while gently manipulating the cuff from the shaft." a review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: BIVONA TIGHT-TO-SHAFT PEDIATRIC FLEXTEND V-NECK 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 ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20833368
• Report Number: 9617604-2024-00906
• Device Sequence Number: 4032493
• Product Code: JOH
• UDI-Device Identifier: 10351688518637
• UDI-Public: (01)10351688518637(17)251108(10)4077101
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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 Expiration Date: 11/08/2025
• Device Catalogue Number: 67PFS45
• Device Lot Number: 4077101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• 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