MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® CUFFED BLUE LINE ULTRA® SUCTIONAID; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/860/080

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that it was suspected that this endotracheal tube exhibited a leak while in use with a patient.The tube was replaced with a new one.No additional adverse patient effects were reported.

Manufacturer Narrative

One used sample was returned for evaluation.The returned device was given functional testing: a syringe was attached and the cuff was filled with air as per device instructions.The cuff was found to fully inflate with no leakage detected.The device was left with cuff inflated for 24 hours; no leakage occurred during the extended testing.The reported issue could not be confirmed.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.This review included the following procedures: basic assembly and cuff inflation testing.The manufacturing facility also performed an in-process visual inspection of 32 products that were in the assembly area: this inspection showed no issues with the products being assembled.The root cause could not be established; the returned device was found to meet with specifications.

• Brand Name: PORTEX® CUFFED BLUE LINE ULTRA® SUCTIONAID
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7642640
• MDR Text Key: 112491797
• Report Number: 3012307300-2018-02422
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 100/860/080
• Device Lot Number: 3509786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/27/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 10/03/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention