MAUDE Adverse Event Report: EQUASHIELD MEDICAL LTD. EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE (E260); CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number SU-E260/2

Device Problems Incorrect Measurement (1383); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

Event Type  malfunction  

Event Description

Equashield syringe unit e260 was used during chemotherapy dilution.When withdrawing 60 ml of drug solution from a unit dose vial, the resultant volume in the syringe was 59 ml.When the same solution was drawn up into 2- 30 ml the combined volume presented in the syringes as 60 ml.We tested two e260 syringes from different lots against each other by withdrawing 50 ml of sodium chloride from a unit dose 50 ml vial.One syringe presented as 50 ml and the defective lot (1720731) presented as 48 ml.We contacted the manufacturer and they let us know that lot 1720731 was defective but within variance by the fda's standards.They said that we could either return the syringes back to their facility or continue using them.I am unsure how we could continue using them if they would not be able to measure the correct volume for chemotherapy iv admixing.I did not feel this was an appropriate response by the company.They requested that we send back the affected lots, however never followed up with a label for shipping or provided an address to send it to.I have attached a picture for your records.

• Brand Name: EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE (E260)
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): EQUASHIELD MEDICAL LTD.; p.o. box 12; tefen industrial park 24959 00; IS 2495900
• MDR Report Key: 7960453
• MDR Text Key: 123801438
• Report Number: MW5080521
• Device Sequence Number: 0
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: SU-E260/2
• Device Lot Number: 1720731
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1