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	67NFPS35
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
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 multiple tracheostomy tubes once processed by csr are being returned to unit with "fuzzy" substance on obturator.There is no patient harm.No medical intervention required.
Additional Manufacturer Narrative
H6.Investigation codes: updated investigation summary: the sample returned consists in three (3) units for p/n: 67nfps35 and l/n: 4334221, returned samples were received in used condition, decontaminated and in a plastic bag.The samples were visually inspected, at 12¿ to 16¿ under normal conditions of illumination.No damage or foreign particles were found in the returned samples; the obturator is clean without fuzzy in any of the three samples.The samples are in good condition.The failure mode was not confirmed.Based on the analysis performed on the sample provided and the reported by the customer, no root cause could be determined since the complaint was not confirmed.The failure mode will continue to be monitored and if a trend is identified an investigation will be opened.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 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: 19486058
• Report Number: 3012307300-2024-04584
• Device Sequence Number: 8030430
• Product Code: JOH
• UDI-Device Identifier: 10351688518798
• UDI-Public: (01)10351688518798(17)270926(10)4334221
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• 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: 67NFPS35
• Device Lot Number: 4334221
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2022
• 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 MO
• Patient Sex: Unknown
• Patient Race: White