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

Model Number	67PFSS40
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The events of this complaint is unknown.Patient involvement unknown.
Additional Manufacturer Narrative
G2 email is: (b)(4).No product sample was returned for investigation, 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.The complaint is not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK TRACH
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 17289922
• Report Number: 3012307300-2023-07052
• Device Sequence Number: 17553162
• Product Code: JOH
• UDI-Device Identifier: 10351688518699
• UDI-Public: 10351688518699
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

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 Expiration Date: 09/04/2026
• Device Model Number: 67PFSS40
• Device Catalogue Number: 67PFSS40
• Device Lot Number: 4179347
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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 Sex: Unknown