MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES MINITRACHEOSTOMY MINI-TRACH; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/461/000

Device Problem Complete Blockage (1094)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2017

Event Type  Death  

Manufacturer Narrative

Device evaluation: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.No dhr review could be completed because there was no product lot number available within the complaint details.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

Event Description

It was reported that on (b)(6) 2017, the patient was admitted to the hospital and on june 14 he underwent surgery for malignant tumor of the pharynx.According to the information obtained, a postoperative airway obstruction caused hypoxic encephalopathy and cerebral edema to occur.The patient died of multiple organ failure.The physician commented that, after puncturing the tuohy needle to the patient, he was able to perform air suction.However, after that, the guide wire was unable to be inserted, so he stopped the medical procedure.In addition, the physician claimed that the event (the guide wire having been unable to be inserted) happened because the patient was obese and also cartilage tissues or some other objects went inside the tuohy needle.No comment was obtained from the physician regarding the cause of the patient death.

• Brand Name: PORTEX TUBES MINITRACHEOSTOMY MINI-TRACH
• 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; minneapolis, MN 55442
• MDR Report Key: 15658183
• MDR Text Key: 302265715
• Report Number: 3012307300-2022-26047
• Device Sequence Number: 1
• Product Code: BTO
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/461/000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• 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
• Patient Outcome(s): Death
• Patient Sex: Male