MAUDE Adverse Event Report: EQUASHIELD MEDICAL LTD. EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE FEMALE LL CONNECTOR; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	FC-1
Health Effect - Clinical Code	Chemical Exposure (2570)
Type of Reportable Event	Malfunction
Event or Problem Description
Patients receiving 5-fu via cadd legacy pump with equashield closed system transfer device female ll connector (fc-1) experienced leakage due to the connector leading to chemotherapy exposure and use of provided spill kits.All patients experienced challenge from the implementation of the product leading to report with the company.The company's recommendation was to use female ll connector swivel (fc-1s).Fda safety report id# (b)(4).

• Brand Name: EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE FEMALE LL CONNECTOR
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD MEDICAL LTD.
• MDR Report Key: 10153246
• Report Number: MW5094987
• Device Sequence Number: 3233949
• Product Code: ONB
• UDI-Device Identifier: 07290013484178
• UDI-Public: (01)07290013484178
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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 Expiration Date: 04/01/2023
• Device Model Number: FC-1
• Device Lot Number: 201962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other