MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL DURAFLEX CATHETER; ANESTHESIA CONDUCTION KIT

Catalog Number	4917M-19
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter stated the user attempted to insert the catheter in patient epidural space but the catheter was "stiff" and this issue caused the user to "hit vascular vessels" which caused bleeding.The procedure was not completed.No adverse effects to patient reported.

• Brand Name: SMITHS MEDICAL DURAFLEX CATHETER
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8718430
• Report Number: 3012307300-2019-02811
• Device Sequence Number: 16697309
• Product Code: CAZ
• UDI-Device Identifier: 00351688047574
• UDI-Public: 00351688047574
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/20/2019

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 Catalogue Number: 4917M-19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1