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

Model Number 101/860/075

Device Problems Deflation Problem (1149); Decrease in Pressure (1490)

Patient Problem Insufficient Information (4580)

Event Date 04/25/2023

Event Type  Injury  

Event Description

It was reported on 25 april that a respirator frequently issued alarms during the use of the product.The cuff air pressure dropped from 30 to about 15, but when air was put into the cuff again, the pressure dropped to 15 again and the alarm sounded.The customer also noticed the deflation occurred too slowly.The customer removed the product to check it, and this time it was unable to be deflated.After the product was changed to another new one, the condition of the patient was settled.

Manufacturer Narrative

Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Device available for evaluation and evaluation codes: updated device evaluation: one decontaminated sample was returned for investigation.Under visual inspection the sample appeared to be in good condition.Functional testing could not duplicate the issue.The complaint was not confirmed.Because no fault was found the device history report (dhr) review was not completed.No trend of similar customer complaints was identified.

• Brand Name: 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16879904
• MDR Text Key: 314672410
• Report Number: 3012307300-2023-05222
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076141
• UDI-Public: 15019517076141
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/075
• Device Catalogue Number: 101/860/075CZ
• Device Lot Number: 4285843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• 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