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

Catalog Number	60PFS45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A5.Ethnicity: scottish.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.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 tracheotomy tube broke and fell out completely whilst the patient, a child, was in bed.This resulted in an emergency tracheostomy tube insertion.The family was alerted to the patient making gasping noises and discovered that patient¿s tracheostomy tube was completely dislodged and laying in the cot.The family quickly carried out an emergency tracheostomy tube insertion.The patient recovered well and this all lasted approximately just over one minute.The family did not feel a medical review was required.The patient had no color change and no change to oxygen saturation or heart rate numbers.The patient's family discovered that the tracheostomy tube had snapped fully through where the neck tape attached.The tracheostomy tube was on the 7th wash.Following a discussion with the patient¿s respiratory team, the patient is now being changed onto a different brand of tracheostomy tube.The operator of the device was the family of the patient.There was no human harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record could not be completed as no lot number was received.

• Brand Name: BIVONA UNCUFFED PEDIATRIC FLEXTEND PLUS 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: 20652110
• Report Number: 9617604-2024-00860
• Device Sequence Number: 8219096
• Product Code: JOH
• UDI-Device Identifier: 15021312005875
• UDI-Public: (01)15021312005875
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: Other
• Device Catalogue Number: 60PFS45
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 3 YR
• Patient Sex: Unknown
• Patient Weight: 13 KG