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

Catalog Number 100/561/080

Device Problem Compatibility Problem (2960)

Patient Problems Bradycardia (1751); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a procedure, it was found that the guide wire of a portex® ultraperc® single dilator technique kit with a blue line ultra® tracheostomy tube was found to be thicker than the catheter.The fault was found while trying to pass the metal guide through the catheter and the guide did not pass.The guidewire's thickness was checked at the step was repeated.During this process, the patient was punctured three times.The catheter was exchanged for a venous catheter and a guide belonging to another kit.During dilation, the patient was desaturated, and transesophageal abundant bleeding was detected by a potential thyroid puncture.It resulted in bradycardia and the use of a mechanical ventilator was necessary.No permanent injury was reported, and the outcome of the incident was reported as resolved.

• Brand Name: PORTEX® ULTRAPERC® SINGLE DILATOR KIT W/ BLUE LINE ULTRA® TRACHEOSTOMY TUBE
• 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 INTERNATIONAL LTD.; 52 grayshill road; cumbernauld, glasgow G68 9 HQ; UK G68 9HQ
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7084330
• MDR Text Key: 93768405
• Report Number: 3012307300-2017-02503
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2020
• Device Catalogue Number: 100/561/080
• Device Lot Number: 3388274
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention