MAUDE Adverse Event Report: NULL PVC - PORTEX TUBES BLUE LINE ULTRA; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 100/860/070

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Other, other text: one smiths medical cadd was returned for analysis in a used condition.Visual inspection was performed under normal conditions of illumination and no discrepancies were found.During testing, a syringe was used to inflate the cuff of the sample and was submerged under water in order to verify for leaks and leak was detected in the pilot balloon.Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be manufacturing.(b)(6).

Event Description

Information was received indicating that during use of a smiths medical pvc - portex tubes blue line ultra, the customer noticed air pressure of the cuff was fluctuating.No patient consequences were reported.No adverse effects were reported.

• Brand Name: PVC - PORTEX TUBES BLUE LINE ULTRA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section G): NULL
• MDR Report Key: 10123057
• MDR Text Key: 194127748
• Report Number: 3012307300-2020-05497
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/860/070
• Device Lot Number: 3806377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1