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

Model Number	EQUASHIELD FEMALE LUER LOCK CONNECTOR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When setting up chemo tubing, put on equashield female swivel connector, verified it was engaged and swiveled without being able to come off tubing.Then started chemo.While chemo was infusing, equashield fc-1s device came off the end of the iv tubing resulting in a spill and need to make new bag of chemo.Manufacturer response for closed antineoplastic and hazardous drug reconstitution and transfer system, equashield (per site reporter).Requested we mail it to them for testing.

• Brand Name: EQUASHIELD
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD MEDICAL LTD; 2 harbor park drive; port washington NY 11050
• MDR Report Key: 21761138
• Report Number: 21761138
• Device Sequence Number: 21001722
• 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): 04/01/2025
• Report Date (Section F): 04/01/2025

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: 2426783A
• 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: 04/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/01/2025