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

Model Number 101/860/080CZ

Device Problem Leak/Splash (1354)

Patient Problem Pneumonia (2011)

Event Date 10/22/2021

Event Type  Injury  

Event Description

The customer started using the product for regular replacement for a patient with encephalitis.On (b)(6) 2021, the customer noticed the pilot balloon was detached from the inflation line and he changed the product to another new one.In the morning of (b)(6) 2022, the patient suffered pneumonia and was undergoing medical treatment (pneumonia was caused by secretion that went into the lung(s)).No further adverse patient effects were reported.

Manufacturer Narrative

Other, other text: two photos were used for investigation.On the photos there is one (b)(6) 8mm deht blu suctionaid sub-assy with detached pilot balloon from inflation line.Similar customer complaints have been recently received therefore internal non-conformity report was raised with purpose to evaluate this issue.

Manufacturer Narrative

No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Manufacturer Narrative

Other, other text: additional information in h10.This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.

• Brand Name: PVC - PORTEX TUBES BLUSELECT
• Type of Device: 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 12808238
• MDR Text Key: 280760064
• Report Number: 3012307300-2021-11182
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/05/2023

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
• Device Operator: Health Professional
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/13/2021
• Supplement Dates Manufacturer Received: 11/10/2021; 04/25/2023; 05/05/2023
• Supplement Dates FDA Received: 12/08/2021; 05/04/2023; 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention