MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX TUBES PDT UNIPERC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/070CZ
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used unit was received for evaluation.The customer claimed there is obturator of size 9.0 in the package of size 7.0.Under visual inspection it was confirmed that the obturator is size 9.0 as reported by customer.Corrective action is in place regarding this issue.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.
Event or Problem Description
It was reported that the package included obturator for size 9.0 instead of size 7, and therefore the obturator did not fit inside the cannula.As the procedure was performed in the operating room, the cannula could be placed in the patient with the help of other instruments.The event occurred in the hospital and there was patient involvement, but no injury.

• Brand Name: PORTEX TUBES PDT UNIPERC
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22554172
• Report Number: 3012307300-2025-08604
• Device Sequence Number: 9637867
• Product Code: BTO
• UDI-Device Identifier: 15019315107191
• UDI-Public: (01)15019315107191(17)271026(10)4281210
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: UNKNOWN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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 Catalogue Number: 100/897/070CZ
• Device Lot Number: 4281210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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