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

Catalog Number	67NFPS35
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that baby with trach and vent was agitated, flailing arms.The trach tube hub disconnected from the body of the trach tube.They believed that it is a swivel adapter.An emergency trach tube change was performed, and the outcome was resolved.
Additional Manufacturer Narrative
H3: other; device 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.
Additional Manufacturer Narrative
The following field was updated with corrections: d4.Primary udi number: (b)(4).D9.Date returned to mfg: 31-may-2024 h6.Investigation codes: updated investigation summary: two photos were received from customer for evaluation, it was observed a broken connector and tracheostomy tube detached.One sample was received in used condition from part number 67nfps35 without original package.The returned sample was inspected under normal conditions of illumination 16¿ to detect any defect.During the visual inspection, the following was detected: a broken connector and silicone detached with tracheostomy tube.The failure mode reported in the complaint was confirmed.A review of the manufacturing process for part number con-flx-050-4 (connector component over molded) and part number 67nfps35 (finished good), was conducted by quality engineer and manufacturing engineer on 13-may-2024 to verify that there are no conditions that could cause the event.Production personnel perform a 100% visual inspection to verify that there are no short shots, cuts, or splits in critical areas from connector.Quality personnel perform a sampling size using an aql 025/ii to verify that there are no short shots, cuts, or splits in critical areas from connector.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause is that damage occurred after the product left the shm facility.Customer complaint notification was conducted with the personnel as awareness of the failure mode reported by the customer.A device history record could not be completed as no lot number was received.

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL 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: 19359666
• Report Number: 3012307300-2024-03987
• Device Sequence Number: 6342418
• Product Code: JOH
• UDI-Device Identifier: 10351688518798
• UDI-Public: (01)10351688518798
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 67NFPS35
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 07/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 MO
• Patient Sex: Female
• Patient Weight: 7 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American