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

Model Number 101/860/080CZ

Device Problem Leak/Splash (1354)

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

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported that during the use of the product, some water droplets were found in the pilot balloon and the cuff.After removing the product from the patient, the customer checked if for leakage, but none was detected.No patient injury.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.One used decontaminated sample 10009163-004 8mm deht blu suctionaid sub-assy was returned for investigation.Customer described that there was a fluid inside inflation system.Tracheostomy tube inflation system is dedicated for inflation of cuff by air.Therefore it shall be perfectly leak proof.There are only two possible reasons for a fluid inside inflation system - inflation system leak (e.G.Fluid can get into inflation system trough cuff tear) or incorrect practice during use which do not respect instructions for use (e.G.Cleaning of inflation system by a fluid/inflation line flushed by a liquid instead of suction line by error/etc.).Under visual inspection the sample appeared to be in good condition.To verify if there is any leak of inflation system we replicated 12 hours inflation test which is done during manufacturing with 100% frequency.It was found that after 12 hours cuff was still fully inflated.Returned device was also submerged in water.No air leak nor fluid inside inflation system was observed.Based on investigation results no fault on returned sample was found.It is the most probable that a fluid was introduced into inflation system due to a practice which is not in compliance with instructions for use.The customer stated problem was not duplicated.The cause of the reported problem was traced to the user manipulation of the device.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID
• 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: 14166701
• MDR Text Key: 289737348
• Report Number: 3012307300-2022-06779
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/25/2022
• 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