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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EQUASHIELD LLC EQUASHIELD SYRINGE UNIT 60 CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

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EQUASHIELD LLC EQUASHIELD SYRINGE UNIT 60 CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Model Number SU-60/2
Device Problems Defective Component (2292); Failure to Deliver (2338)
Patient Problem Insufficient Information (4580)
Event Date 02/18/2021
Event Type  No Answer Provided  
Event Description
When compounding the iv bag with bevacizumab with the equashield closed system supplies. When the pharmacist withdrew the medication from the vial and injected it into the iv bag, the medication was not going into the iv bag. Rather, the medication was being transferred to the other side of the plunger inside the equashield syringe. It was a defective equashield syringe. Lot number of su-60: 205484l, lot number of sa-1t: 205355a. Fda safety report id# (b)(4).
 
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Brand NameEQUASHIELD SYRINGE UNIT 60
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
EQUASHIELD LLC
MDR Report Key11384906
MDR Text Key234022548
Report NumberMW5099644
Device Sequence Number1
Product Code ONB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberSU-60/2
Device Lot Number205484L
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 02/25/2021 Patient Sequence Number: 1
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