MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BLUE LINE VOCALAID ® TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 100/517/080

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that while a tracheostomy vocalaid was in use, the suction line broke off.The patient required a trach change out.No adverse effects were experienced by the patient.

Manufacturer Narrative

Device evaluation: one portex vocalaid sample was received in used condition without its original packaging.Immediate visual inspection detected that the suction line was detached.Operator training records were reviewed to ensure operators are trained in line clearance, tube cutting, and bonding operation.No discrepancies were found.The vocalaid tube cutting and bonding operations were also audited during thirty two (32) units finding no discrepancies, no excess solvent, and no damaged tubes.A review of the manufacturing process was conducted and was considered adequate and correct.In attempt to reproduce the reported allegation, the device was cut and stretched.The tests found that the sample did not appear to be cut, but the suction line was likely stretched until it broke.Based on the evidence and investigation, the complaint was confirmed.The problem source was stated to be unknown.

• Brand Name: PORTEX® BLUE LINE VOCALAID ® TRACHEOSTOMY TUBE
• 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: 7598363
• MDR Text Key: 110965403
• Report Number: 3012307300-2018-02270
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 100/517/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention