MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA NEONATAL PEDIATRIC TIGHT TO SHAFT FLEXTEND; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67NFPS30
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the user experienced difficulty from the balloon in the cannula.It was reported as "defective.Eppi remained in the spotlight.Ineffectiveness of nocturnal niv (non-invasive ventilation)." more information was obtained indicating that the reported problem occurred during use on the patient.No medical intervention required.No clinical consequences.No medical treatment.The status of this incident was reported as "ongoing".Unknown medication involved in the event.Resolution to the event was not reported.
Additional Manufacturer Narrative
E1: reporter phone number 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.
Additional Manufacturer Narrative
H3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device sample was received in used condition without the original packaging.Per visual inspection, no visual defects were identified in the sample.The sample was inflated with the use of a syringe and submerged under water to detect any problem in the inflation system.The device performed as expected and no leaks found.The complaint was not confirmed.No other device analysis was performed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken since the complaint could not be confirmed.The reported failure mode will continue to be monitored.Five devices were reported, and one device sample returned for investigation ((b)(4)).

• Brand Name: BIVONA NEONATAL PEDIATRIC TIGHT TO SHAFT FLEXTEND
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18376097
• Report Number: 9617604-2023-00026
• Device Sequence Number: 12662685
• Product Code: JOH
• UDI-Device Identifier: 10351688518781
• UDI-Public: (01)10351688518781(17)280105(10)4352759
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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 Catalogue Number: 67NFPS30
• Device Lot Number: 4352759
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2023
• 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
• Patient Sex: Unknown