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 Problems Air Leak (1008); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that the cuff of this tracheostomy tube leaked while in use with a patient.It was noted that medical intervention was required.No additional adverse patient effects were reported.

Manufacturer Narrative

One smiths medical portex® bivona® adult tts¿ tracheostomy tube was returned for analysis in a used condition.No discrepancies were found during visual examination.A syringe was used to inflate the cuff as it was submerged under water detecting a leak; verifying complaint.Relevant documents were reviewed and deemed adequate.The manufacturing process was conducted.Cuff assembly operation was reviewed and inflation line assembly operation was reviewed with no discrepancies found.Inflation test was audited during thirty two (32) units by performing in accordance to the test method stated in the manufacturing procedure; no deflated cuffs were detected during the thirty two (32) units tested.Based on the evidence the complaint was confirmed but the root cause is unknown.

• 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
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7363211
• MDR Text Key: 103226302
• Report Number: 3012307300-2018-00793
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 09/04/2018

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: Health Professional
• Device Expiration Date: 07/16/2021
• Device Catalogue Number: 100/860/080
• Device Lot Number: 3231477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 08/07/2018
• Supplement Dates FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention