MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES NEO/PED AIRE-CUF; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	65P035
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during patient use the tracheostomy tube split.It was removed from the patient and new tracheostomy inserted.There was no patient or clinical injury and no medical intervention occurred as the parent changed the tracheostomy.The outcome of event was new tracheostomy tube in full working order.The pre-existing conditions was pierre robin syndrome.Home ventilated via tracheostomy 24 hours/day.
Additional Manufacturer Narrative
Other text: d4: catalog number, lot number, expiration date, udi number, d5.Operator of device, e1: address and h4: device manufacture date is unknown, no information 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
Additional information was received providing the item number of the involved device.
Additional Manufacturer Narrative
Other, other text: additional information is provided for d.10, h.2, h.3, and h.6.One sample was received for evaluation.Visual inspection revealed the device was split.Functional testing was performed, and the reported issue was able to be replicated.The root cause was unable to be determined.No lot number was provided; therefore, a history record review could not be conducted.For all enquiries or follow-up questions related to the record, do not use (b)(4) located in sections g.1., please direct those to the following: (b)(4).

• Brand Name: BIVONA TUBES NEO/PED AIRE-CUF
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 18136152
• Report Number: 3012307300-2023-10500
• Device Sequence Number: 7982980
• Product Code: JOH
• UDI-Device Identifier: 15021312005967
• UDI-Public: 15021312005967
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2024

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?: No
• Operator of Device: Other
• Device Catalogue Number: 65P035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/14/2023; 02/09/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 01/08/2024; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 MO
• Patient Sex: Female