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

Model Number 101/860/070

Device Problem Material Puncture/Hole (1504)

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

Event Date 02/01/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: month and year of event have been provided, day is unknown.One decontaminated product was received for investigation.Under visual inspection the sample appeared to be in good condition.An inflation test was performed on the received sample.It was found that sample cannot pass this 12-hour test as cuff was deflating during inflation from a tear in the cuff.Due to fact that a cuff leak was not observed prior use it is the most probable that reported failure occurred during tracheostomy procedure or during use due to contact with a sharp edge.A device history record (dhr) review shows there were no observations recorded during manufacturing of the reported lot number.No further action has been taken at this time.

Event Description

It was reported that during the use of the product, a pinhole (or a torn hole) was found in the cuff.No adverse patient effects were reported by the customer.It was reported that no further information is available.

• Brand Name: PORTEX TUBES BLUSELECT 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17050539
• MDR Text Key: 316410416
• Report Number: 3012307300-2023-05974
• 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
• Report Date: 06/02/2023

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: 101/860/070
• Device Catalogue Number: 101/860/070CZ
• Device Lot Number: 4252464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1