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

Model Number	60HA30
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a size 3 tracchie with a size 3.5 base plate.No patient injury was reported.
Additional Manufacturer Narrative
A review of the returned product confirmed the neck flange plate was printed 3.5mm id and the shaft measured 3.0 mm.A review of the device history record (dhr)for the lot number, confirmed the shaft and connector portions of the device were 3.0 mm id components.The sliding neck flange issued to the lot was a 3.5 mm id.The portion of the device that is inserted into the body matched the part number associated with the identified lot number.A distributed product risk review, corrective action plans, were initiated.A global ship hold was unable to be initiated since there were no remaining units of the lot in inventory.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA TUBES NEO/PED HYPERFLEX
• 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): 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: 15454705
• Report Number: 3012307300-2022-19725
• Device Sequence Number: 6880837
• Product Code: JOH
• UDI-Device Identifier: 15021312013696
• UDI-Public: 15021312013696
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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: 06/12/2024
• Device Model Number: 60HA30
• Device Catalogue Number: 60HA30
• Device Lot Number: 3794165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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