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

Catalog Number 100/891/070CZ

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Please see mfr # 3012307300-2018-02420 for related device incident.

Event Description

User facility reported the flexible metal guide didn't slip in the needle during the setting up of the tracheostomy procedure, and it was later added that this was due to the operator's incorrect use/set up of the device.

• Brand Name: PORTEX® PERCUTANEOUS BLUE LINE ULTRA® SUCTIONAID® TRACHEOSTOMY KIT
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC A. S.; olomouck 306; hranice 1 - mesto; hranice, 75301 ; EZ 75301
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7622656
• MDR Text Key: 111853001
• Report Number: 3012307300-2018-02546
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060945
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 100/891/070CZ
• Device Lot Number: 2847537
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1