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

Model Number	EQUASHIELD FEMALE LUER LOCK CONNECTOR
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Hooking up female equashield to a flush to prepare to give chemo.Checking swivel to ensure proper attachment and the flush came off.Unsure of whether the flush or the female equashield was at fault, had charge nurse come attach two pieces together and had the same issue.Each time connecting this flush with equashield the flush was becoming detached despite triple checking the swivel.This made this flush and equashield not suitable to give chemo through and another flush and equashield had to be used to achieve proper safety features when giving chemo.

• Brand Name: EQUASHIELD
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD LLC; 2 harbor park drive; port washington NY 11050
• MDR Report Key: 24579033
• Report Number: 24579033
• Device Sequence Number: 9233203
• Product Code: ONB
• UDI-Device Identifier: 07290013484536
• UDI-Public: (01)07290013484536
• 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): 01/13/2026
• Report Date (Section F): 01/13/2026

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: EQUASHIELD FEMALE LUER LOCK CONNECTOR
• Device Catalogue Number: FC-1S
• Device Lot Number: 2529083A
• 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: 03/12/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/13/2026