MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX MINI-TRACH II - NON SELDINGER KIT; CRICOTHYROTOMY KIT

Catalog Number 100/461/000

Device Problem Bent (1059)

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

Event Date 04/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

Information was received indicating that during use with a patient, a guidewire to a smiths medical portex® mini-trach® ii - non seldinger kit was found to be bent.There were no reported adverse effects.

Manufacturer Narrative

The investigation was unable to be performed because the guidewire was not returned with the sample.Additionally, a trend analysis evaluation was not possible because the lot number of the product was not provided.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: PORTEX MINI-TRACH II - NON SELDINGER KIT
• Type of Device: CRICOTHYROTOMY KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7514077
• MDR Text Key: 108251616
• Report Number: 3012307300-2018-01420
• Device Sequence Number: 1
• Product Code: OGP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/461/000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1