MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUPERC AND BLUGRIGGS PERCUTANEOUS DILATI; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/891/070CZ

Device Problem Disconnection (1171)

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

Event Type  malfunction  

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.It was found to be a supplied item fault.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.

Event Description

It was reported that during the use of the product, the inflation line got detached from the pilot balloon.No patient injury.No additional information is available for this complaint.

• Brand Name: PORTEX BLUPERC AND BLUGRIGGS PERCUTANEOUS DILATI
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 14626149
• MDR Text Key: 293881115
• Report Number: 3012307300-2022-11021
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315106873
• UDI-Public: 15019315106873
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/07/2022

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: 100/891/070CZ
• Device Catalogue Number: 100/891/070CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1