MAUDE Adverse Event Report: EPIMED INTERNATIONAL, INC. 20G SPIROL CATHETER; CATHETER, CONDUCTION, ANESTHETIC

Lot Number 16367913

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 02/10/2018

Event Type  malfunction  

Event Description

Epidural connection leaking, therefore, patient did not receive full dose of meds.

• Brand Name: 20G SPIROL CATHETER
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): EPIMED INTERNATIONAL, INC.; 141 sal landrio dr.; crossroads business park; johnstown NY 12095
• MDR Report Key: 7428298
• MDR Text Key: 105397012
• Report Number: 7428298
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2018,04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2022
• Device Lot Number: 16367913
• Other Device ID Number: 20 G SHORT EPIDURAL CATHETER
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR