MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. SPIROL CATHETER

Model Number A-EP-098

Device Problems Device Damaged by Another Device (2915); Device Handling Problem (3265); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Event Description

While placing a catheter from a t-bloc tray (with epimed catheter) for nerve block for a total knee surgery the catheter broke.While the catheter was being threaded through, the catheter got kinked.Therefore, the catheter was pulled back out.However, when the catheter was pulled out, the tip of the catheter was sheared.

• Brand Name: SPIROL CATHETER
• Type of Device: SPIROL CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer (Section G): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer Contact: nate wrabel ; 141 sal landrio drive; johnstown, NY 12095 ; 5188483919
• MDR Report Key: 7455531
• MDR Text Key: 219195355
• Report Number: 1316297-2018-00001
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A-EP-098
• Device Catalogue Number: N/A
• Device Lot Number: 053017SC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• 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
• Patient Outcome(s): Other