MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® PORTEX® ULTRAPERC® SINGLE DILATOR KIT; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	100/562/000CZ
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that guidewire was unable to be inserted during procedure into the 14g needle.New kit was then used to resolve.
Additional Manufacturer Narrative
Device evaluation: one used decontaminated sample of 007/910/680 blu tracheostomy tube 8.0mm s/assy 1/ea was received in plastic bag without its original packaging.This component is not included in reported tracheostomy tube kit 100/562/000cz.No guidewire nor 14g needle which is described as problematic as per complaint description were received.Based on complaint description doctor wanted to insert 008/108/781 guidewire pack tube into 005/078/190 needle and cannula 14g which is not in compliance with process which is described in ifu 004/005/245a (l6394 rev.103).As per ifu (section 11.2 - 11.6) guidewire shall be inserted into cannula - not directly into needle.Dhr review summary:following dhrs were reviewed: finish good work order 100/562/000cz lot 3710346, manufacturing date 2018-10-19, quantity 136pcs; good inwards records for 005/078/190 needle and cannula lot 18e15b, 2000pcs received in june 2018; good inwards records for 008/108/781 guidewire pack tube lot 276775, 2500pcs received in june 2018; a review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.The customer reported condition was not confirmed.

• Brand Name: PORTEX® PORTEX® ULTRAPERC® SINGLE DILATOR KIT
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8363634
• Report Number: 3012307300-2019-00895
• Device Sequence Number: 13979811
• Product Code: JOH
• UDI-Device Identifier: 15019315106750
• UDI-Public: 15019315106750
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K040014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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
• Operator of Device: No Information
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 100/562/000CZ
• Device Lot Number: 3710346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1