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

Model Number	67PFS45
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed samples were received in used conditions without their original packaging, with their certificate of safe handling and with their obturator.Visual inspection was performed under normal lighting to received units, in order to detect any damage on the cuff.No discrepancies were found.Customers reported issue was duplicated.Test showed a discrepancy in symmetry when inflating the cuffs completely.Three samples were below the minimum acceptable specification.The root cause of the reported issue was not determined.Actions taken to mitigate the reported issue: an alert was generated in order to improve cuff bonding operation to prevent asymmetrical cuffs.Production personnel was trained on quality alert by area trainer.A corrective and preventative action has been opened to address the reported issue.
Event or Problem Description
It was reported that three balloons were unequally inflating.No patient injury reported.

• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15668353
• Report Number: 3012307300-2022-26162
• Device Sequence Number: 12373040
• Product Code: JOH
• UDI-Device Identifier: 10351688518637
• UDI-Public: 10351688518637
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

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: 06/26/2023
• Device Model Number: 67PFS45
• Device Catalogue Number: 67PFS45
• Device Lot Number: 3662806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2018
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown