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

Model Number	60P045
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
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).A device history record review (dhr) was conducted which indicated all inspections were completed and no issues were noted during manufacture.One image and five samples were received for evaluation.Visual inspection was performed at 12' under normal lighting to received unit.According with visual inspection, the inner box has an incorrect expiration date and tray has the correct expiration date; therefore the complaint is confirmed.During the investigation analysis, the failure mode reported was reproduced.Label software was verified, and it was observed that problem occurred during data capturing, manually operated information captured incorrectly and this caused an incorrect expiration date on labels.The corrective action was documented in a non-conformance.A scanning system was implemented to replace the manual capture of the number of shelf-life days for the product.It is documented in the procedure and was implemented.It meets the requirements to prevent / correct the failure mode reported in the complaint about incorrect expiration date.
Event or Problem Description
It was reported that five boxes of tracheostomy show expired on the label with an expiration date of 17 march 2021.However, in the states that the lot does not expire until 17 march 2026.Photo attached.No patient injury reported.

• Brand Name: BIVONA TUBES NEO/PED
• 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: 16330644
• Report Number: 3012307300-2023-01060
• Device Sequence Number: 17747249
• Product Code: BTO
• UDI-Device Identifier: 15021312005769
• UDI-Public: 15021312005769
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2023

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: 05/04/2021
• Device Model Number: 60P045
• Device Catalogue Number: 60P045
• Device Lot Number: 4125816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown