MAUDE Adverse Event Report: EPIMED INTERNATIONAL REGIONAL ANESTHESIA CATHETER; 20 GAUGE SPIROL CATHETER

Catalog Number 193-2036

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Event Description

The account reported the wire reinforcement came out from the tip of the catheter when it was removed after being difficult to advance.

• Brand Name: REGIONAL ANESTHESIA CATHETER
• Type of Device: 20 GAUGE SPIROL CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL; 141 sal landrio drive; crossroads business park; johnstown NY 12095
• Manufacturer (Section G): EPIMED; 141 sal landrio drive; crossroads business park; johnstown NY 12095
• Manufacturer Contact: 141 sal landrio drive; crossroads business park; johnstown, NY 12095 ; 5188483901
• MDR Report Key: 10929979
• MDR Text Key: 226852590
• Report Number: 1316297-2020-00001
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 10/01/2020

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: Health Professional
• Device Catalogue Number: 193-2036
• Device Lot Number: 163610290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1