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

Model Number	EQUASHIELD FEMALE LUER LOCK CONNECTOR
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Chemical Exposure (2570)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Mother walked out of room and said tubing had come disconnected when they set patient on the floor to play.I walked in and immediately paused the chemotherapy (chemo) channel that was infusing 24 hour cytarabine.3 drops of chemo liquid were noted on playmat and was wiped up.Equashield female and male piece still attached to clave on patient's port with blood backed up and starting to come out of equashield pieces.Tubing had come unattached from swivel connector that luer locks on and shouldn't be able to be disconnected.I had started the chemo the day before and twisted this piece around to ensure that it was securely in place.

• Brand Name: EQUASHIELD
• 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: 21158053
• Report Number: 21158053
• Device Sequence Number: 7655911
• 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): 12/06/2024
• Report Date (Section F): 12/06/2024

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
• Device Model Number: EQUASHIELD FEMALE LUER LOCK CONNECTOR
• Device Catalogue Number: FC-1S
• Device Lot Number: 2421361A
• 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: 01/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• 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 Age: 24 MO
• Patient Sex: Prefer Not To Disclose
• Date Report Sent to FDA: 12/06/2024