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

Model Number	SU-5/2
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Equashield closed system transfer device, 5ml syringe, lot 219669a is leaking from the bottom of the syringe onto employee's hand.There isn't supposed to be liquid beneath the plunger.There is liquid beneath the plunger and not air.Fda safety report id # (b)(4).

• Brand Name: EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD MEDICAL LTD.; port washington NY 11050
• MDR Report Key: 13798046
• Report Number: MW5108208
• Device Sequence Number: 5008439
• Product Code: ONB
• UDI-Device Identifier: 07290013484031
• UDI-Public: (01)07290013484031
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

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: 11/01/2024
• Device Model Number: SU-5/2
• Device Catalogue Number: SU-5/2
• Device Lot Number: 219669A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2022
• 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: Required Intervention
• Patient Sex: Unknown