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
Medical Device Problem Codes	Failure to Advance (2524); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7852532
• Report Number: 3012307300-2018-03678
• Device Sequence Number: 13768904
• Product Code: BTO
• UDI-Device Identifier: 15019315028793
• UDI-Public: 15019315028793
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060945
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 10/23/2022
• Device Catalogue Number: 100/541/080
• Device Lot Number: 3524301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1