MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUSELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/870/075CZ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the customer was performing a suction for the top of the cuff, the suction line connector got detached.No patient injury reported.
Additional Manufacturer Narrative
No product information has been provided to date.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.
Additional Manufacturer Narrative
Conclusion codes: updated device evaluation: one used, decontaminated device was received for investigation.Visual inspection noted a piece of suction line tubing was still inside the connector (bonded with the connector).The suction line tubing was separated from connector near the connector entrance.The device was sent to a second investigation site for further root cause analysis.At the second investigation site only the connector was received, the connector was detached from the tube and a piece of tube was identified inside the connector, confirming the complaint.Based on the analysis conducted in the sample and photos provided of the sample, the occurrence of this failure condition could be caused by the incorrect use of the product, since a portion of the suction line tubing remains inside the connector, indicating that the union was correct and due to an external force, the tubing was pulled out of the connector.A review of the device history record (dhr) could not be completed as no lot number was provided.No corrective actions are required since the main cause of the detachment problem is improper use of the product.

• Brand Name: PORTEX TUBES BLUSELECT
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16129879
• Report Number: 3012307300-2023-00300
• Device Sequence Number: 11576448
• Product Code: BTO
• UDI-Device Identifier: 15019517076219
• UDI-Public: 15019517076219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 101/870/075CZ
• Device Catalogue Number: 101/870/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Life Threatening
• Patient Sex: Unknown