MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLU SELECT SUCTIONAID CUFFED; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/870/090
Medical Device Problem Codes	Component Incompatible (1108); Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Codes	Aspiration Pneumonitis (4455); Insufficient Information (4580)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the health professional experienced issues during use with a patient.The issues include the malfunctioning of the subglottic suction valve on the newly inserted tracheostomy tube.Additionally, the cuff of the tracheostomy tube exhibited immediate leakage after insertion, "prompting the need for multiple tube changes".This situation is of particular concern as the patient undergoing these changes is at high risk of aspiration.An unused sample from the same lot is available for investigation.The event has affected the patient care and a medical intervention was necessary.Description of the medical intervention: the client stated only "tk change, survey of laboratory parameters, and antibiosis".The event has occurred in hospital.It is unknown if there was an injury or not."4 or 5 samples are affected.However only one sample of the same lot number is available for investigation." products were affected during 01-nov-2023 and 14-nov-2023, therefore no exact dates could be provided.A1: one patient, and five product malfunctions were reported.(b)(6) both represent the same patient.This is the first malfunction report for the related complaints.
Additional Manufacturer Narrative
Other text: d3, g1, and g2 email is: (b)(6).Device evaluation: one unused sample in it's original packaging was received for investigation.Under visual inspection the sample appeared to be in good condition.Inflation testing was repeated on the received sample.It was confirmed that after 12 hours the cuff was still fully inflated.The suction line was visually inspected.No damage nor deformation was observed.Using a syringe connected to the blue connector, suction was checked.No issue was found.The vacuum control valve was visually inspected.No nonconformity was found.Based on results of testing the reported failures were not observed.No trend of similar customer complaints was identified.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.No action taken.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: PORTEX BLU SELECT SUCTIONAID CUFFED
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18321024
• Report Number: 3012307300-2023-11018
• Device Sequence Number: 7438380
• Product Code: BTO
• UDI-Device Identifier: 15019517076240
• UDI-Public: (01)15019517076240(11)221122(17)271026(10)4303381
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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: 101/870/090
• Device Catalogue Number: 101/870/090CZ
• Device Lot Number: 4303381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown