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

Model Number	SA-EZ
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Rn spiking etoposide chemotherapy.Rn spiked tubing.When etoposide was picked up to prime, spike fell out of equashield where alaris tubing spikes into equashield piece spiked by pharmacy.Etoposide then spilled out of bag, exposing staff.Manufacturer response for closed antineoplastic and hazardous drug reconstitution and transfer system, spike adaptor ez (per site reporter).Requested permission to come on site for additional staff education.

• Brand Name: SPIKE ADAPTOR EZ
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD MEDICAL LTD; 2 harbor park drive; port washington NY 11050
• MDR Report Key: 21546814
• Report Number: 21546814
• Device Sequence Number: 15187063
• Product Code: ONB
• UDI-Device Identifier: 07290013484666
• UDI-Public: (01)07290013484666
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2025
• Report Date (Section F): 01/27/2025

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
• Device Model Number: SA-EZ
• Device Catalogue Number: SA-EZ
• Device Lot Number: 2425920B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/27/2025