MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX TUBES BLUE LINE ULTRA (BLU); TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 100/870/090

Device Problems Leak/Splash (1354); Product Quality Problem (1506); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Event date: (b)(6) 2019 - only the year (2019) is known.Report source: foreign country: (b)(6).Device evaluation in progress.

Event Description

It was reported that after intubating the patient with the device, the operator noticed that the cuff got damaged.The nature of the damage was not stated.A tube change out was not performed.No medical intervention was provided.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

One blue line ultra (blu) tracheostomy tube was returned for analysis in used conditions.No water was found in the tube upon visual inspection.The cuff was inflated with a syringe while submerged in water; burble coming out of a small tear in the cuff.Relevant documents and the manufacturing process were both reviewed and deemed adequate.The cuff assembly and the inflation line assembly were reviewed; no discrepancies found.Inflation testing was performed on 32 units from the production floor; no deflated cuffs were found.Based on the evidence, the complaint is confirmed.However, the root cause is unknown.

• Brand Name: PORTEX TUBES BLUE LINE ULTRA (BLU)
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9597897
• MDR Text Key: 177173682
• Report Number: 3012307300-2020-00287
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/870/090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 03/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1