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

Model Number	LL-1
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Faulty equashield.Fda safety report id# (b)(4).

• Brand Name: EQUASHIELD
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD LLC
• MDR Report Key: 12546878
• Report Number: MW5104255
• Device Sequence Number: 16530908
• Product Code: ONB
• UDI-Device Identifier: 07290013484185
• UDI-Public: 07290013484185
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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 Expiration Date: 08/01/2024
• Device Model Number: LL-1
• Device Lot Number: 218498A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1