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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol b10010116, 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 eleven samples were received for evaluation in unused conditions and had original packaging.Visual inspection was performed at 12 inches under normal lighting to received unit.According to the visual inspection, the inner box had an incorrect expiration date and tray had the correct expiration date; therefore, the complaint was confirmed.During the investigation analysis, the failure mode reported was reproduced.Label software was verified, and it was observed that a 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 11 tracheostomy tubes with the same item number and lot number had an expiration date that was the same as the manufacture date on the box.No patient injury was reported, the issue was discovered during pre-testing.

• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16809713
• Report Number: 3012307300-2023-04522
• Device Sequence Number: 11502935
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023

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: Lay User/Patient
• Device Expiration Date: 03/17/2026
• 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: 09/13/2021
• 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: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• 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