MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES BLUE LINE ULTRA SUCTIONAID TRACHEOSTO; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/860/080

Device Problem Connection Problem (2900)

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

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

Device serial number/lot number and pma/510(k) are unknown, no product information has been provided to date.No lot number provided, no fault found.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found the sample appeared to be in good condition.Functional testing found that the inflation valve stayed fully connected to cuff inflator luer slip port - no disconnection as reported by customer was observed.There was no fault found.Manufacturing device history record review could not be conducted because no lot number was provided.

Event Description

It was reported that when connecting the cuff port and the pressure gauge, it is not fixed and bounces off, so accurate pressure measurement is not possible.Tested it to replace it with another product and the same problem occurred.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

• Brand Name: PORTEX TUBES BLUE LINE ULTRA SUCTIONAID TRACHEOSTO
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; gwangjin-gu seoul; minneapolis, MN 55442
• MDR Report Key: 15769815
• MDR Text Key: 306796757
• Report Number: 3012307300-2022-27004
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K030570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/860/080
• Device Catalogue Number: 100/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1