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

Catalog Number	101/870/080CZ
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.Date of event: unknown.No information has been provided to date.E3 - initial reporter occupation unknown.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 the tube information sticker attached to their file does not include the lot number and the expiry date.There was patient involvement, and no harm reported.
Additional Manufacturer Narrative
Investigation summary: the investigation of the complaint was limited because no sample was returned.The investigation was done based on the photo provided by customer via e-mail.The customer is claiming the missing informations (lot number and expiry date) on the patient and warning label.The patient and warning label consists of two parts.The first part of the label mentioned by customer that sticks to the tracheostomy tube does not contain information regarding the lot number and expiry date.This information is given on the second part of the label.No trend of confirmed similar customer complaints nor internal nonconformity was identified.Therefore, this issue is considered to be isolated incident only with unknown root cause.A device history record could not be completed as no lot number was received.

• Brand Name: PORTEX BLUSELECT SUCTIONAID CUFFED TRACHEOSTOMY 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: 20320953
• Report Number: 3011237704-2024-00201
• Device Sequence Number: 18049933
• Product Code: BTO
• UDI-Device Identifier: 15019517076226
• UDI-Public: (01)15019517076226
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Followup
• Report Date (Section B): 11/21/2024

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: 101/870/080CZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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