MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67SP035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device has not been returned to date.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 both devices broke at the wing.One cannula was thrown away, the other is available for investigation.There was patient involvement, but no patient harm/adverse event reported.
Additional Manufacturer Narrative
H6.Evaluation codes: updated.At the time of this investigation the physical device was not received at the investigation site, and no pictures were provided by the customer.Without the return of the samples a comprehensive failure investigation cannot be carried out, and a probable cause cannot be determined.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is received the manufacturer will re-open the complaint for further device analysis.
Additional Manufacturer Narrative
One device was received for evaluation.Visual and functional testing was unable to duplicate the reported problem.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20039839
• Report Number: 3012307300-2024-08022
• Device Sequence Number: 6574068
• Product Code: JOH
• UDI-Device Identifier: 15021312000719
• UDI-Public: (01)15021312000719(17)280812(10)4424741
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 12/26/2024

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: Lay User/Patient
• Device Catalogue Number: 67SP035
• Device Lot Number: 4424741
• 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: 08/02/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 12/02/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/07/2024; 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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 Sex: Unknown