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

Catalog Number 4917M-19

Device Problem Output Problem (3005)

Patient Problem Blood Loss (2597)

Event Date 05/10/2019

Event Type  malfunction  

Event 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8722823
• MDR Text Key: 148814525
• Report Number: 3012307300-2019-03591
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00351688047574
• UDI-Public: 00351688047574
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K092657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4917M-19
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1