MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TUBES NEO/PED FLEXTEND; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67PFSS25
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation and 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 an 8-month-old infant hospitalized for a postnatal diagnosis of poly malformative syndrome.When changing the tracheostomy cannula, the health professional noticed that drops of eppi were coming out of the cuff when testing the cuff with 2ml of eppi.The cuff was not inflated properly and the cannula was not placed.There has been no report of patient injury or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing was performed.Visual inspection found no damage could be detected.Functional testing found the cuff inflated successfully; the complaint was not confirmed.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA TUBES NEO/PED FLEXTEND
• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15403240
• Report Number: 3012307300-2022-18752
• Device Sequence Number: 6197925
• Product Code: JOH
• UDI-Device Identifier: 10351688518668
• UDI-Public: 10351688518668
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/10/2023

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: 12/11/2023
• Device Model Number: 67PFSS25
• Device Catalogue Number: 67PFSS25
• Device Lot Number: 3744766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• 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: 08/16/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2019
• 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: 8 MO
• Patient Sex: Unknown