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

Model Number	101/851/080
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is unknown.Device evaluation: one device was received for investigation.Under visual inspection we noticed that inner cannula is cracked/damaged.Investigation results indicates that it is most probable that the reported failure occurred due to excessive force used during cleaning or an incorrect cleaning technique.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 products.
Event or Problem Description
It was reported that degradation/deterioration of inner liners in less than a month after installation.The reported problem occurred during use on the patient."no consequences for the patient, without medical treatment.".

• Brand Name: PORTEX TUBES BLUSELECT SUCTIONAID
• 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: 18959233
• Report Number: 3011237704-2024-00070
• Device Sequence Number: 18482750
• Product Code: BTO
• UDI-Device Identifier: 15019517076660
• UDI-Public: (01)15019517076660(17)270629(10)4285953
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 101/851/080
• Device Catalogue Number: 101/851/080CZ
• Device Lot Number: 4285953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown