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

Model Number 101/860/070

Device Problem Inflation Problem (1310)

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

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that during the use of the product, air pressure of the cuff got lowered easily.No patient injury.No additional information is available for this complaint.

Manufacturer Narrative

Month and year of event have been provided, day is unknown; lot number is unknown, no information has been provided to date.A product sample was received and is awaiting evaluation, investigation 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

Device evaluated by manufacturer and h6.Event problem and evaluation codes: updated.One decontaminated sample was returned for investigation.Under visual inspection the sample appeared to be in good condition.During manufacturing process, the devices are 100 percent inflation tested, which includes inflating each device cuff and leaving for a twelve (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 confirmed that after twelve (12) hours the cuff was still fully inflated.Based on results of testing the reported failure was not observed.A device history record (dhr) review could not be performed as the lot number of the device is unknown.

• Brand Name: PORTEX BLU SELECT SUCTIONAID TRACHEOSTOMY TUBE
• 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; 7-1-1 akasaka; minneapolis, MN 55442
• MDR Report Key: 16305592
• MDR Text Key: 308890994
• Report Number: 3012307300-2023-00911
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/070
• Device Catalogue Number: 101/860/070CZ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1