MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUPERC PERCUTANEOUS DILATION KIT WITH SINGLE STAGE DILATOR AND 9.0 M; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	101/563/090
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D5: operator of device is unknown.E2 - incorrect due to system limitations.Initial reporter was the account sales representative.H3 - other: device has not been returned to date.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.
Event or Problem Description
It was reported that when the purchased product arrived, the operator checked it and found a sample sticker on the box.No patient involvement reported.There was no patient harm/adverse event reported.
Additional Manufacturer Narrative
D9: 25-dec-2023.H3 and h6 - evaluation codes: updated.Device evaluation: (b)(4) unopened packages were returned with original packaging.There were sample labels label on each unit box.The complaint was confirmed.The inspection worker misunderstood the procedure.Although he was not instructed to attach a sample sticker, he misunderstood that a sample sticker would be attached if he filled out the address, so he ended up attaching a sample sticker.Root cause was attributed to packaging.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.Action taken: sample stickers were removed from the inspection table.The operation has been changed to attaching the required number of sample stickers to the picking list when sorting it.

• Brand Name: PORTEX BLUPERC PERCUTANEOUS DILATION KIT WITH SINGLE STAGE DILATOR AND 9.0 M
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucka 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18545686
• Report Number: 3011237704-2024-00019
• Device Sequence Number: 8914982
• Product Code: JOH
• UDI-Device Identifier: 15019517103427
• UDI-Public: (01)15019517103427(17)260522(10)4384984
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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: Other
• Device Expiration Date: 05/22/2026
• Device Catalogue Number: 101/563/090
• Device Lot Number: 4384984
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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