MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH 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	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: month and year of event have been provided; day is unknown.H3: other; device not returned to manufacturer.One (1) photo was provided by the customer, which was used to conduct the device analysis, the device sample was not received.Unable to confirm the reported complaint.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Event or Problem Description
It was reported that the cuffs were inflating unevenly and will create uneven pressure on the trachea.The issue was discovered prior to use.There was no patient involvement and no patient harm.No medical intervention required.Outcome of the event was ongoing.
Additional Manufacturer Narrative
D9: 25-apr-2024.H3 and h6 - evaluation codes: updated.Device evaluation: one sample was received in used condition, in a plastic bag.During visual inspection no damage or other defects were detected on the sample.The sample was inflated with the use of a syringe to detect any problem in the inflation system.It was observed that cuff inflated as expected and symmetry value was 35 percent.The complaint was not confirmed.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.This issue will continue to be monitored and further actions taken accordingly.A2; h6 and h10 - device was returned and codes and investigation findings have been updated accordingly.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19100460
• Report Number: 9617604-2024-00322
• Device Sequence Number: 12664230
• Product Code: JOH
• UDI-Device Identifier: 10351688518637
• UDI-Public: (01)10351688518637(17)280604(10)4400638
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: 67PFS45
• Device Lot Number: 4400638
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2023
• 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 Age: 5 YR
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic