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

Catalog Number	67N035
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.During visual inspection it was identified that one portion of the cuff was adhered to the tube.The cuff was massaged while the pilot balloon was squeezed and the cuff inflated symmetrically.The test is done according to the instructions for use.The failure of the broken cuff was not confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Event or Problem Description
The customer reported: " on the afternoon of 04-apr-2024, during a patient's tracheostomy tube change by the orl doctor and the medical and paramedical teams in the pediatric intensive care unit, damaged and non-compliant cannulas (glued cuff and glued and damaged plastic) were found.After opening 5 different boxes, they finally found a usable cannula." there was patient involvement, but there were no consequences of the event.There was risk of deterioration of the patient's condition (risk of infectious hygiene or respiratory infection) if the damaged cannula may have been used.The device is not available for evaluation.The number of devices involved from lot 3904655 is 2, but only one is available for investigation.
Additional Manufacturer Narrative
H3 - other: device has not been returned 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.

• Brand Name: BIVONA NEONATAL TIGHT TO SHAFT TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19274503
• Report Number: 3012307300-2024-03544
• Device Sequence Number: 6335531
• Product Code: JOH
• UDI-Device Identifier: 15021312006223
• UDI-Public: (01)15021312006223(17)241201(10)3904655
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2024
• Device Catalogue Number: 67N035
• Device Lot Number: 3904655
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2020
• 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
• Patient Sex: Unknown