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

Model Number	60P050
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol b10009704, as a result of warning letter cms#: 617147.510k is unknown.No information has been provided to date.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.A product sample was received for evaluation.Visual and functional testing were performed.One (1) sample was received from its closed original packaging in new conditions.Visual inspection was performed at 12 under normal lighting to received unit.During the visual inspection, it was seen that the box label and the lid label did not match.The information for use inside the box was reviewed and it was correct according to its label.The product inside the tray was observed and all the components were correct according to its label.The most probable root cause was that after a review of the different verifications that are performed during the manufacturing process to detect mixing components and since the products were manufactured with two years of difference, the most probable root cause was that mixing occurred after the product left the facility.The following actions were taken: as a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.
Event or Problem Description
It was reported that the customer stated the item number on the box was different from the label inside the box.No patient injury was reported.

• Brand Name: BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUB
• 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: 15625446
• Report Number: 3012307300-2022-24823
• Device Sequence Number: 6345655
• Product Code: BTO
• UDI-Device Identifier: 15021312005776
• UDI-Public: 15021312005776
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: 03/27/2024
• Device Model Number: 60P050
• Device Catalogue Number: 60P050
• Device Lot Number: 3835767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2019
• 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): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown