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U.S. Department of Health and Human Services

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

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EQUASHIELD MEDICAL LTD. EQUASHIELD CLOSED SYSTEM TRANSFER DEVICE (E260) CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
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.
 
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Brand NameEQUASHIELD CLOSED SYSTEM TRANSFER DEVICE (E260)
Type of DeviceCLOSED 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 Key7960453
MDR Text Key123801438
Report NumberMW5080521
Device Sequence Number0
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received10/11/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/01/2019
Device Model NumberSU-E260/2
Device Lot Number1720731
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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