MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX BLUE LINA ULTRA SUCTIONAID TRACH TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 100/860/080

Device Problem Gas/Air Leak (2946)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/12/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Event Description

It was reported that the patient was admitted to the hospital for cerebral hemorrhage and was treated surgically at 09:00 on (b)(6) 2022 in accordance with the doctor's instructions, and the patient was intubated and equipped with sputum suction tracheostomy during the operation.The airbag leakage phenomenon was found and was replaced immediately, causing secondary puncture injury to the patient.No other additional information has been provided at this time.

• Brand Name: PORTEX BLUE LINA ULTRA SUCTIONAID TRACH 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): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; muping district; minneapolis, MN 55442
• MDR Report Key: 15651834
• MDR Text Key: 306929516
• Report Number: 3012307300-2022-25740
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030570
• 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: 10/21/2022

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: 100/860/080
• Device Catalogue Number: 100/860/080CZ
• Device Lot Number: 3996106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1