MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	67PFSS45
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event 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
It was reported, that the cuff on a 4.5mm tracheostomy tube was "faulty".And would not inflate.Therefore, it could not be used.No patient injury or clinical affects was reported.
Event or Problem Description
Additional information received via email.Customer reported that the fault was discovered prior to patient use and there was no patient harm.No medical intervention was required.The event was resolved by using a different tracheostomy tube that did not have the fault.Relevant history: smard, tracheostomy ventilator dependent.Date of incident (b)(6)2023 at the patient's home.
Additional Manufacturer Narrative
Other, other text: additional information is provided in b.7.H.2., and h.6.The product was not returned for evaluation.One photo of the sample was added for investigation.According to what is observed in the photo, it is not possible to identify the reported condition because the photo only shows the product information.As a result, product evaluation and problem confirmation cannot be performed.No corrective actions are required since the complaint was not confirmed.If the sample is returned, the investigation will be reopened to complement the analysis of the affected device.The product's history records were reviewed and there were no non-conformances that would have resulted in the reported complaint.For all enquiries or follow-up questions related to the record, do not use (b)(6).

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 17186997
• Report Number: 3012307300-2023-06558
• Device Sequence Number: 6248653
• Product Code: JOH
• UDI-Device Identifier: 10351688518705
• UDI-Public: 10351688518705
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• 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): 03/22/2024

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: Other
• Device Model Number: 67PFSS45
• Device Catalogue Number: 67PFSS45
• Device Lot Number: 4216318
• Was Device Available for Evaluation?: No
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 02/29/2024
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/21/2023; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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
• Patient Age: 11 YR
• Patient Sex: Unknown
• Patient Weight: 30 KG
• Patient Race: White