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

Model Number	Equashield Syringe Unit
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse wanted to administer the doxorubicin (adriamycin) it started to leak from the equashield syringe from the tip and from the adapter.A 60 mg syringe, lot number is 206001a, expiration 01/12/2023, ndc 07290013484079.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 MEDICAL LTD.
• MDR Report Key: 11505835
• Report Number: MW5100027
• Device Sequence Number: 11719871
• Product Code: ONB
• UDI-Device Identifier: 07290013484079
• UDI-Public: 07290013484079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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: No Information
• Device Expiration Date: 01/12/2023
• Device Model Number: Equashield Syringe Unit
• Device Lot Number: 206001A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2021
• Patient Sequence Number: 1