MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	HU16LS50NGG090S
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that the customer received a wrong size customized bivona at beginning of november.It was delivered to the hospital; patient came last week for checking but cannula was a wrong size 5.0mm.According to custom form it should have been with other parameters.They suspected that they have a wrong vendor code behind item custom bivona.Additional information received by smiths medical/icu on 10-jan-2023 via email: the customer reported that the the outcome of the event was patient did not get new canyla.Event date (b)(6) 2022.
Additional Manufacturer Narrative
Other, other text: h6.Health impact, event problem and evaluation codes: updated.Reviewed the provided images of the labeling and device.Reviewed the device history record (dhr) for the reported lot number and all records indicate that the device was made to the correct template.If the complainant wanted changes (e.G., id size, shaft length, etc.) made to the existing custom part number a new template needed to be provided when placing the order, which would have initiated a new part number.The investigation did not identify a manufacturing issue.The root cause was determined to be a miscommunication during the order process between the party that placed the order and the customer service representative who processed the order.

• Brand Name: BIVONA CUSTOM TRACHEOSTOMY TUBE
• 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: 16194606
• Report Number: 3012307300-2023-00528
• Device Sequence Number: 5807251
• Product Code: JOH
• UDI-Device Identifier: 15019517088809
• UDI-Public: 15019517088809
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 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 Model Number: HU16LS50NGG090S
• Device Catalogue Number: HU16LS50NGG090S
• Device Lot Number: GB000498
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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 Sex: Unknown