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

Model Number 101/860/070CZ

Device Problem Obstruction of Flow (2423)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported that during the use of the product, sucking fluid through the suction line was unable to be performed.No patient injury was reported.

Manufacturer Narrative

No lot or serial numbers were communicated; device expiration date and device manufacturing date not available.Device evaluation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated no lot number was provided; therefore, device history record review could not be performed.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection found no defect nor deformation was observed.Functional testing found no problem nor abnormality was observed - air was passing trough suction line both ways without any problem.Device passed all functional testing, unable to replicate the reported issue.No problem found.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.

• Brand Name: PVC - 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; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 15807394
• MDR Text Key: 303854350
• Report Number: 3012307300-2022-27257
• 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: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2022
• 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