MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 3.5 TIGHT TO SHAFT FLEXTEND; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	FT18EN35NSF146S
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot number, full udi, expiration date, and h4: manufacture date are not available as no lot number has been provided to date.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 swivel adaptor cracked on the tracheostomy tube, while is use with a patient.Trach change completed without issue.No disruption to ventilation.No harm to the patient.
Additional Manufacturer Narrative
Date returned to mfg: 03-apr-2024.Investigation summary: one 3.5 flextend device with a swivel connector was received for evaluation.Visual inspection confirmed that there was a crack on the base / ledge of the swivel.The instruction for use, 10018908-001, states under warnings to always hold the base of the 15mm connector when disconnecting.If difficulty is experienced when disconnecting, utilize the disconnect wedge provided by inserting the thin end between the connectors and pushing to force them apart.Also under warnings, the ifu states to use only water-soluble lubricants with this tube.Use of petroleum-based lubricants could damage this tube.Acetone is another chemical if used on the connecter with crack the connector.Review of complaints for a crack connector at the base did not identify a trend.If appropriate cleaning solvents and ointments were used, the crack is likely due to an inadvertent force that was applied to the base / ledge of the connector.The investigation did not determine a manufacturing defect with the sample.A device history record could not be completed as no lot number was received.

• Brand Name: BIVONA CUSTOM 3.5 TIGHT TO SHAFT FLEXTEND
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18951090
• Report Number: 1824231-2024-00027
• Device Sequence Number: 17979090
• Product Code: JOH
• UDI-Device Identifier: 15019517155464
• UDI-Public: (01)15019517155464
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: FT18EN35NSF146S
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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: 12 MO
• Patient Sex: Male