MAUDE Adverse Event Report: EQUASHIELD MEDICAL LTD. EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE LUER LOCK ADAPTOR; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	LL-1
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was receiving 5-fu via cadd legacy pump with equashield closed system transfer device female ll connector swivel (fc-1s) and equashield luer lock adaptor (ll-1).The adapter disconnected and exposed the patient to 5- fu which lead to the patient being coached by phone to stop the cadd pump, utilize a chemo spill kit, and then return to our facility for additional treatment.New pump cartridge filled and started on a new pump.Patient had an exposure to her hands and into an open cut that lead to burning and irritation.Treatment provided by nurses on site for exposure.Prior challenges experienced with equashield female ll connector (fc-1) leading to leaks, after which, the company recommended use of fc-1s.This leak was attributed to disconnection of the ll-1.Fda safety report id# (b)(4).

• Brand Name: EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE LUER LOCK ADAPTOR
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD MEDICAL LTD.; IL
• MDR Report Key: 10153222
• Report Number: MW5094986
• Device Sequence Number: 3233948
• Product Code: ONB
• UDI-Device Identifier: 07290013484185
• UDI-Public: (01)07290013484185
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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: 02/01/2023
• Device Model Number: LL-1
• Device Lot Number: 200803
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Weight: 48