MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA PEDIATRIC 3.5 TIGHT TO SHAFT, CUFFED; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67SP035
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
Two devices were returned for evaluation in used condition, decontaminated and in a plastic bag.Visual inspection was performed, no damage or foreign particles were found in the returned samples; the obturator was clean without the fuzzy material in both samples.The failure mode was not confirmed.No root cause could be determined since the complaint was not confirmed due sample provided does not shows the failure mode reported.The failure mode will continue to be monitored and if a trend is identified an investigation will be opened.
Event or Problem Description
It was reported that the tracheostomy tube had a "fuzzy" substance on obturator.There was no medical intervention required.There was patient involvement and no patient harm reported.

• Brand Name: BIVONA PEDIATRIC 3.5 TIGHT TO SHAFT, CUFFED
• 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: 19722393
• Report Number: 9617604-2024-00571
• Device Sequence Number: 8290351
• Product Code: JOH
• UDI-Device Identifier: 15021312000719
• UDI-Public: (01)15021312000719
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2024

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: 67SP035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 8 MO
• Patient Sex: Unknown
• Patient Race: White