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

Model Number 100/860/075

Device Problem Suction Problem (2170)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 11/13/2022

Event Type  Injury  

Manufacturer Narrative

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 required.

Event Description

It was reported that the nurse found that the patients trach tube could not be properly suctioned.The nurse checked and found that the subglottic suction tube was broken.The gas cutting sleeve was replaced with a new one.

Manufacturer Narrative

Other, other text: no product sample was received, therefore visual and functional testing could not be performed.As no lot number was provided, a review of manufacturing device history records could not be conducted.The customer's description of the issue was reviewed, but the manner of the described break in the suction tube could not be clearly determined from the description.Based upon the available information, the investigation could not confirm the reported issue or attribute a root cause.No actions have been taken at this time.If the product is returned, the manufacturer will reopen this complaint for further investigation.

Manufacturer Narrative

Corrected information - model number and catalog number updated.

• Brand Name: PORTEX BLUE LINE 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): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; nanjing, jiangsu province; minneapolis, MN 55442
• MDR Report Key: 16258364
• MDR Text Key: 308305028
• Report Number: 3012307300-2023-00711
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: 100/860/075
• Device Catalogue Number: 100/860/075CZ
• Device Lot Number: 4115203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• 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): Required Intervention
• Patient Age: 68 YR