MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PERCUTANEOUS TRACHY KIT 8.0MM WITH WIRE DILATING FORCEPS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/541/080

Device Problems Failure to Advance (2524); Positioning Problem (3009)

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

Event Type  malfunction  

Event Description

It was reported that the guide wire did not pass through the needle and into the tracheostomy cannula.

• Brand Name: PERCUTANEOUS TRACHY KIT 8.0MM WITH WIRE DILATING FORCEPS
• 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.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7852532
• MDR Text Key: 119429511
• Report Number: 3012307300-2018-03678
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315028793
• UDI-Public: 15019315028793
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/06/2018

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: 10/23/2022
• Device Catalogue Number: 100/541/080
• Device Lot Number: 3524301
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1