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

Model Number 101/860/080CZ

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  Injury  

Event Description

It was reported that during the use of the product, the suction line got kinked (or bent), which caused an occlusion in it to occur, not allowing the customer to perform suction properly.So he stopped using the product.No patient injury reported.

Manufacturer Narrative

Device serial number/lot number is unknown, no product information has been provided to date.No lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.It was observed that there was no kind of kink or the device being bent as described by customer.Suction line is flexible tubing and it can be easily kinked when inappropriately handled.Furthermore we noticed that suction line is cut near its connection with suction connector.On suction connector there were found cuts and dents (the most probably caused by forceps) which indicates inappropriate handling.The root cause of the reported issue was found to be that the damage of the product (suction line cut and suction connector damage) happened due to inappropriate handling by customer.

Manufacturer Narrative

H6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.One used decontaminated sample was returned for investigation.Under visual inspection we did not observe any kind of kink or bent as described by customer.Suction line is flexible tubing and it can be easily kinked when inappropriately handled.Furthermore we noticed that suction line is cut near its connection with suction connector.On suction connector there were found cuts and dents (the most probably caused by forceps) which indicates inappropriate handling.Based on visual inspection we did not find any problem on suction line which might lead to reported occlusion.The cause of the reported problem, damage of product (suction line cut and suction connector damage) happened due to inappropriate handling by customer.No lot number was provided; therefore, dhr (device history review) could not be performed., corrected data: h1: correction: type of reportable event: serious injury.

• Brand Name: 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; 7-15-26 fukushima; minneapolis, MN 55442
• MDR Report Key: 16122656
• MDR Text Key: 306934580
• Report Number: 3012307300-2023-00263
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening