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	02/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Equashield malfunctioned.Able to circle prime and put on pump.When i went to attach vincristine to the patient through the female adaptor, the female connetor (fc-1s) came comletely off.Vincristine spilled from bag and tubing.New bag of vincristine had to be obtained.

• 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: 21558822
• Report Number: 21558822
• Device Sequence Number: 9601488
• 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): 02/06/2025
• Report Date (Section F): 02/06/2025

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: 2425893A
• 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: 03/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2025
• 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 Age: 13 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/06/2025