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	60PFSS45
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two device samples were received in used condition without original package.During the visual inspection, a cut of eyelets was observed in both samples.The complaint was confirmed.A root cause has not been determined and the complaint fault has been escalated to address a full root cause investigation.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Event or Problem Description
It was reported that there were two trachs with broken flanges.Both trachs failed while in use with the patient with no patient harm reported.Moreover, it was stated that home nurse had to replace both broken traches with their last primary back-up one due to broken flanges on both units.There was patient involvement with no patient harm/adverse event reported.A1: one patient, two product malfunctions.Emdr-25371 and emdr-25636 both represent the same patient.This is the first malfunction report for the related complaints.

• 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: 19533137
• Report Number: 9617604-2024-00530
• Device Sequence Number: 7483611
• Product Code: JOH
• UDI-Device Identifier: 15021312516791
• UDI-Public: (01)15021312516791(17)290129(10)4453905
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 60PFSS45
• Device Lot Number: 4453905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR
• Patient Sex: Unknown
• Patient Weight: 25 KG