MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX PERCUTANEOUS KIT WITH BLUSELECT TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/543/080
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the outer packaging box of the product they received had a different lot and list number from the inner packaging.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3 and h6.Codes: updated.One device sample, no forceps was received for investigation.Under visual inspection it was confirmed that there is a label on the shelf carton with item number 101/561/080 with lot 4382035.The inner packaging contains a different product with item number 101/543/080 and lot number 4382017.The complaint issue has been escalated and corrective actions are in process.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.

• Brand Name: PORTEX PERCUTANEOUS KIT WITH BLUSELECT TRACH TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20292476
• Report Number: 3011237704-2024-00195
• Device Sequence Number: 18145684
• Product Code: BTO
• UDI-Device Identifier: 15019517103342
• UDI-Public: (01)15019517103342(17)260425(10)4382017
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2024

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: 04/25/2026
• Device Catalogue Number: 101/543/080
• Device Lot Number: 4382017
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown