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

Model Number	67P035
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation 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 customer reports two defective tracheostomy tubes: the cuff didn't inflate in one case and it partially inflated then deflated in the other.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Device evaluation: two sample was returned for investigation.The returned samples were received in unused condition inside a plastic bag.The sample was visually inspected under normal conditions of illumination to detect conditions that could cause functional issues.No obstructions, damaged, broken, or other defects were detected in none of the joins of the product.For functional testing, the samples were filled with air (leak test) to see if there was any functional problem, then the cuff was measured for symmetry.The cuff was inflated symmetrically for two samples; complaint was not confirmed.No fault was found with the sample.Root cause was not addressed since the cuff had inflated symmetrically, and no corrective action was taken since the complaint was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA TUBES NEO/PED TTS
• 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: 15734910
• Report Number: 3012307300-2022-26732
• Device Sequence Number: 6317142
• Product Code: JOH
• UDI-Device Identifier: 15021312006261
• UDI-Public: 15021312006261
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: Lay User/Patient
• Device Expiration Date: 12/02/2025
• Device Model Number: 67P035
• Device Catalogue Number: 67P035
• Device Lot Number: 4086022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2022
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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