MAUDE Adverse Event Report: EQUASHIELD LLC EQUASHIELD; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	EQUASHIELD FEMALE LUER LOCK CONNECTOR
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At approximately 1556, call light was pressed and nursing staff entered room to etoposide line unhooked at the female equashield and tubing connection and dripping blood onto the bed.Per rn report, prior to starting the medication, 2 rns ensured that swivel collar on tubing was pulled back, tubing was secured into equashield and then collar was pulled down and tightened.Manufacturer response for closed antineoplastic and hazardous drug reconstitution and transfer system, equashield (per site reporter).They are sending a cannister to have the device shipped to them for testing.

• Brand Name: EQUASHIELD
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD LLC; 2 harbor park drive; port washington NY 11050
• MDR Report Key: 22318157
• Report Number: 22318157
• Device Sequence Number: 8858006
• Product Code: ONB
• UDI-Device Identifier: 07290013484536
• UDI-Public: (01)07290013484536
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/06/2025
• Report Date (Section F): 06/06/2025

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 Model Number: EQUASHIELD FEMALE LUER LOCK CONNECTOR
• Device Catalogue Number: FC-1S
• Device Lot Number: 2527869A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/24/2025
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/06/2025