MAUDE Adverse Event Report: EQUASHEILD 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	Insufficient Information (4580)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medication was dripping out of the connection from the tubing.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): EQUASHEILD MEDICAL LTD.
• MDR Report Key: 12727937
• Report Number: MW5105032
• Device Sequence Number: 1454716
• Product Code: ONB
• UDI-Device Identifier: 07290013484178
• UDI-Public: (01)07290013484178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2021

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: FC-1
• Device Catalogue Number: 22720000FC1
• Device Lot Number: 217030A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1