MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX PERC DILATION KIT W/ SINGLE STAGE DILATOR & BLUSELECT SUCTIONAID TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/563/080
Medical Device Problem Codes	Crack (1135); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 suctionaid port cracked, making it difficult to aspirate secretions on patients with the potential to cause increased risk in aspiration pneumonia.Occurring in multiple tubes now on the blu select portex suctionaid tube.The event occurred in the hospital while in use with patient and the device was operated by a healthcare professional.The issue was not revolved.There was a need to mark the tubes and highlight the problem and have the whole tube changed when the patient was able to.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: one used decontaminated sample was returned for investigation.Under visual inspection suction connector seems to be without any defect.Then a luer slip syringe was inserted into the connector and crack was observed.Based on the analysis conducted in the samples provided, the returned sample has a crack at the tip of the blue suction connector, this defect can be caused by applying excessive force when connecting the syringe or during the connection of the suction device.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.The failure mode will continue to be monitored and if a trend is identified an investigation will be opened.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.
Event or Problem Description
It was reported that the suctionaid port cracked, making it difficult to aspirate secretions on patients with the potential to cause increased risk in aspiration pneumonia.Occurring in multiple tubes now on the blu select portex suctionaid tube.The event occurred in the hospital while in use with patient and the device was operated by a healthcare professional.The issue was not resolved.There was a need to mark the tubes and highlight the problem and have the whole tube changed when the patient was able to.There was patient involvement and patient harm/adverse event reported.
Additional Manufacturer Narrative
The following fields were updated with additional information: b5.Describe event or problem: "there was patient involvement and patient harm/adverse event reported." the following fields were updated with corrections: b1.Adverse event/product problem: product problem, adverse event.B2.Outcomes attributed to ae: required intervention.H1.Type of reportable event: serious injury.H6.Impact code: f2301, f1905, f23.

• Brand Name: PORTEX PERC DILATION KIT W/ SINGLE STAGE DILATOR & BLUSELECT SUCTIONAID 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 lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19220830
• Report Number: 3011237704-2024-00096
• Device Sequence Number: 6961056
• Product Code: BTO
• UDI-Device Identifier: 15019517103410
• UDI-Public: (01)15019517103410(17)260714(10)4405216
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2024

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 Expiration Date: 07/14/2026
• Device Catalogue Number: 101/563/080
• Device Lot Number: 4405216
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 06/24/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/18/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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