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

Model Number	60SN040
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during the device history record review.The cosmetic box case and unit package were returned.As a result of checking the sample, there was difference between the label and the contents of the cosmetic box and the individual wrapping.In addition, the japanese label and the english label of the cosmetic box were the same, and the labels and contents of the unit package were all the same.In the labeling process, the label of the cosmetic box and the unit package are printed at the same time, and the label is continuously attached.Therefore, the cosmetic box and unit package will have the same product number and lot label.It was confirmed the manufacturing period and shipping time of each lot, but there was no overlap in the period, and there was a difference of 2 years or more, so there is no possibility that the cosmetic box and unit package were mistakenly mixed.The root cause was determined to have occurred after the shipment.Action taken was to notify overseas manufacturers of the occurrence of this event and record this event in a database to monitor the future occurrence status.
Event or Problem Description
It was reported that during the pre-use check, the customer noticed a product with cuff was enclosed in the package.However, the product model number printed on it was one without cuff.No patient injury was reported.

• Brand Name: BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16861933
• Report Number: 3012307300-2023-04982
• Device Sequence Number: 12127705
• Product Code: BTO
• UDI-Device Identifier: 15021312000184
• UDI-Public: 15021312000184
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: 02/19/2025
• Device Model Number: 60SN040
• Device Catalogue Number: 60SN040
• Device Lot Number: 3952369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2020
• 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