MAUDE Adverse Event Report: EPIMED INTERNATIONAL, INC Epimed; CATHETER, CONDUCTION, ANESTHETIC

Model Number	194-2036
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Md using touhy needle during surgery prolene suture was threaded through the touhy needle and introduced into abdomen, while needle was inside patient and manipulated by the surgeon the needle snapped off at the base of the touhy.The surgeon retrieved if from the abdomen.

• Brand Name: Epimed
• Common Device Name: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): EPIMED INTERNATIONAL, INC; 141 sal landrio dr.; crossroads business park; johnstown NY 12095
• MDR Report Key: 50752379
• Report Number: 50752379
• Device Sequence Number: 9550362
• Product Code: BSO
• UDI-Device Identifier: 00818788021649
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/29/2026
• Report Date (Section F): 06/29/2026

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: Health Professional
• Device Model Number: 194-2036
• Device Catalogue Number: 194-2036
• Device Lot Number: 163614003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/29/2026