MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLU SELECT SUCTIONAID, CUFFED, NON-FENESTRATED, 7.0; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/860/070CZ
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿the cannula was applied to the patient on (b)(6) 2024 and the medical personal saw on (b)(6) 2024 that the cannula is faulty.When asked how the patient was affected or if there was harm, the user facility reported: "it is hard to say if the patient was injured.There have probably been occasions when you have not been able to aspirate mucus in the subglottic canal because you did not notice the air leak." the device is not available to be returned for investigation.The event was resolved with a new trach to replace the malfunctioning one.There was no un-planned or emergent trach change.The change was planned.
Additional Manufacturer Narrative
D4: lot number, expiration date, full udi, and h4: manufacture date are unknown; no information has been provided to date.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No lot number has been provided, therefore no device history report (dhr) review could be performed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PORTEX BLU SELECT SUCTIONAID, CUFFED, NON-FENESTRATED, 7.0
• 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: 19021150
• Report Number: 3011237704-2024-00077
• Device Sequence Number: 20831573
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: (01)15019517076134
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K173384
• 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
• Type of Report: Initial
• Report Date (Section B): 04/02/2024

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 Catalogue Number: 101/860/070CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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