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

Model Number 101/870/080CZ

Device Problem Leak/Splash (1354)

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

Event Date 03/23/2022

Event Type  Injury  

Event Description

It was reported that during the use of the product, leakage of air from the product was observed.No patient injury.

Manufacturer Narrative

H10: device evaluation: one used decontaminated sample 10009163-004 8mm deht blu suctionaid sub-assy 1/ea* was returned for investigation without its original packaging.Under visual inspection we noticed a tear in cuff (see photo and video of defect).During manufacturing process the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received sample.It was found that it is not even possible to inflate cuff as it leaks so badly.Due to fact that cuff leak was observed after placement it is the most probable that reported failure occurred during tracheostomy procedure or during use.The cause of the reported problem was traced to the user actions.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.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• 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; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 14208530
• MDR Text Key: 290082749
• Report Number: 3012307300-2022-06963
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076226
• UDI-Public: 15019517076226
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

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: 101/870/080CZ
• Device Catalogue Number: 101/870/080CZ
• Device Lot Number: 4070522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 05/17/2022; 05/06/2023
• Supplement Dates FDA Received: 06/02/2022; 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2020
• 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