MAUDE Adverse Event Report: EQUASHIELD MEDICAL LTD EQUASHIELD SYRINGE UNIT 20; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	SU-20/2
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While drawing up pertuzumab into an equashield syringe, we noticed there was a floating piece of what appears to be black rubber.We believe the floating black piece may be from the plunger of the equashield syringe.It is also possible that it originated from the pertuzumab vial.Refer to additional documents in i2k.

• Brand Name: EQUASHIELD SYRINGE UNIT 20
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD MEDICAL LTD
• MDR Report Key: 18799588
• Report Number: MW5152100
• Device Sequence Number: 12598287
• Product Code: ONB
• UDI-Device Identifier: 07290013484055
• UDI-Public: (01)07290013484055
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 02/22/2024

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: 11/01/2025
• Device Catalogue Number: SU-20/2
• Device Lot Number: 2214999A
• 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: 02/27/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown