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

Model Number	LUER LOCK ADAPTOR SWIVEL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Iv cytarabine was infusing.Equashield connections checked when chemo started, all with tight seals.With 0.7ml of cytarabine flush left, this rn was called to the room and saw drops of blood on the bed.Port line that had chemo running had blood backed up through the equasheild and appeared to be leaking around leur lock site between equashield and iv tubing.Rn unable to detach them, equashield able to spin.Port lumen was flushed with brisk blood return.Held tubing as remainder of chemotherapy flush was infused without issue or noted leaking.Iv set up placed in bag with equashield's and set aside.

• 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: 21547021
• Report Number: 21547021
• Device Sequence Number: 7098962
• Product Code: ONB
• UDI-Device Identifier: 07290013484659
• UDI-Public: (01)07290013484659
• 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): 01/14/2025
• Report Date (Section F): 01/14/2025

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: LUER LOCK ADAPTOR SWIVEL
• Device Catalogue Number: LL-2S
• 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: 01/14/2025