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

Catalog Number 100/813/060CZ

Device Problems Break (1069); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

One used portex tubes blue line ultra (blu) tracheostomy tube (6.0mm uncuffed, fenes, inner cannula) was received in a plastic bag without its original packaging.Under visual inspection it was noticed that the inner cannula had a clear cut in the fenestration area.It was also noticed that there were some scratches inside the tube.The wall thickness of the inner cannula in the damaged area was measured by digital caliper and was found to be within specification (specification is > 0.4mm, measured value).

Event Description

It was reported that the inner cannula broke when nurse was suction through to clean out the tube.No death or serious injury was reported in connection with this incident.

Manufacturer Narrative

One product sample was returned for evaluation.It was received in used condition without the original packaging.Visual inspection of the device has found no discrepencies.The reported complaint was unable to be confirmed.

• Brand Name: PORTEX TUBES BLUE LINE ULTRA (BLU)
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7630857
• MDR Text Key: 112223613
• Report Number: 3012307300-2018-02417
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

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 Expiration Date: 11/28/2018
• Device Catalogue Number: 100/813/060CZ
• Device Lot Number: 2605330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1