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

Catalog Number 100/860/080JP

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Foreign : (b)(6).

Event Description

Information was received that a smiths medical portex blue line tracheostomy tube cuff did not inflate while in use.Subsequently, it was noted tracheostomy (trach) tube replacement was required.No additional adverse patient effects were reported.

Manufacturer Narrative

Other, other text: this mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.A product sample was received for evaluation.Visual and functional testing were performed.Physical condition of the device showed it was received in used conditions without its original packaging.Customers reported issue was confirmed.A syringe was used to inflate the cuff of the sample and was submerged under water in order to verify for leaks.Leaks was detected in the cuff of the returned simple.The root cause of the reported issue was not determined.Actions taken to mitigate the reported issue as preventive action, manufacturing personnel were notified by the supervisor and quality engineer about failure mode reported by the customer.A corrective and preventative action has been opened to address the reported issue.Additional information provided in b1, b5, d10, g4, h6.

• Brand Name: PORTEX BLUE LINE TRACHEOSTOMY TUBE
• 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 ASD, INC.; 6000 nathan lane north; 627-1 yokouchi komaki-shi; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8097659
• MDR Text Key: 128180737
• Report Number: 3012307300-2018-08337
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/860/080JP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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