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

Model Number 101/860/070CZ

Device Problem Suction Problem (2170)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the customer noticed that no suction was able to be performed.So he changed the product to another one.He then checked the removed product for occlusion by injecting air into it using a syringe and a burst sound was heard and he confirmed air was passing through the removed product.The customer suspected there was an occlusion in the suction line.No patient injury.

Manufacturer Narrative

(b)(4) unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.Therefore, according pfmea the occurrence of this failure condition could be caused by: thf (tetrahydrofuran) excess, due to tube submerged more than one time into the solvent dispenser.An awareness complaint notification to the production personnel was conducted by quality engineer on 26-jan-2022 for the defect reported by the customer.Dhr review was done, no issues related to the original complaint were found.

• 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12764064
• MDR Text Key: 280469484
• Report Number: 3012307300-2021-10817
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076134
• UDI-Public: 15019517076134
• 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: 03/08/2022

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: 101/860/070CZ
• Device Catalogue Number: 101/860/070CZ
• Device Lot Number: 4052498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1