MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® PORTEX® ULTRAPERC® SINGLE STAGE DILATOR TECHNIQUE KIT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/563/090

Device Problems Accessory Incompatible (1004); Difficult or Delayed Positioning (1157)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that when using the portex® portex® ultraperc® single stage dilator technique kit with blue line ultra® tracheostomy tube, the enclosed dilator was too small.In addition, the curvature followed a smaller radius.This set included a smaller dilator that left a gap several millimeters wide between the dilator and the wall of the tracheostomy tube.Passing the puncture site, the free wall of the tracheostomy tube "caught" in the puncture channel and could not be advanced.Another puncture kit from the same lot contained the appropriate dilator for a 9 mm cannula.No adverse health outcomes were reported.

Manufacturer Narrative

No product returned for analysis.However, a photograph was returned of two defected samples that were accompanied with a certificate of safe handling.A review of the part number confirmed that the kit should contain an introducer.Based on the returned piece in the photo indicates that customer received the wrong introducer.A review of 248 pieces (lot 3644294) were inspected with no discrepancies.The operators instruction for kitting products and assembly packaging instructions were reviewed noting that there are no clear instructions to emphasis the kitting procedure.Based on the evidence, the allegation was confirmed and the root cause is from manufacturing.

• Brand Name: PORTEX® PORTEX® ULTRAPERC® SINGLE STAGE DILATOR TECHNIQUE KIT
• 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: 7594229
• MDR Text Key: 110848538
• Report Number: 3012307300-2018-02246
• 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: 11/13/2018

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: Health Professional
• Device Expiration Date: 09/05/2021
• Device Catalogue Number: 100/563/090
• Device Lot Number: 3588219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1