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

Model Number 101/860/070

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

It was reported that during the use of the product, a pinhole in the cuff was found, from where leakage of air was observed.No adverse patient effects were reported by the customer.It was reported that no further information will be available.

Manufacturer Narrative

B3: month and year of event have been provided, day is unknown.D4: lot number, expiration date and h4: device manufacture date is unknown, no information has been provided to date.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

Evaluation codes: updated device evaluation: one used and decontaminated device was received for investigation.Under visual inspection we noticed that there is tear in pilot balloon, confirming the complaint.Functional testing was repeated on the received sample.It was found that sample cannot pass this 12 hour leak test; the cuff was deflating during inflation from tear in pilot balloon.No lot number was provided therefor a device history report (dhr) review could not be completed.Due to fact that 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.

• 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: 16864528
• MDR Text Key: 314506788
• Report Number: 3012307300-2023-05006
• 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: 06/07/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/03/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/07/2023
• 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