MAUDE Adverse Event Report: SMITHS HEALTHCARE MFG PORTEX® BLUE LINE ULTRA® SUCTIONAID TRACHEOSTOMY TUBE KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/870/080

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

User facility reported that the hose for filling the cuff was torn down after 20 days in use.No adverse health outcome information was known.

Manufacturer Narrative

The reported b/l ultra suctionaid w/inn cann 8.0mm was returned for investigation.The returned device was received inside a plastic bag and without its original packaging.Visual inspection was at a distance of 12" to 24" and normal conditions of illumination and it was confirmed that pilot balloon is detached from the inflation line.Verification of thf (tetrahydrofuran) adhesive levels were performed in order to detect if levels are lower or upper than indicated; the result observed were that the levels were lower than the ideal level of thf needed.This caused the adhesive to not attach properly to the inflation line to the balloon.The complaint and root cause were confirmed.(b)(4).

• Brand Name: PORTEX® BLUE LINE ULTRA® SUCTIONAID TRACHEOSTOMY TUBE KIT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MFG; s.a.dec.v. ave, calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a.dec.v. ave, calidad no. 4; parque industrial internaciona; tijuana, bc 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul 55112 ; 7633833074
• MDR Report Key: 5784335
• MDR Text Key: 49234136
• Report Number: 2183502-2016-01392
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2021
• Device Catalogue Number: 100/870/080
• Device Lot Number: 3117897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1