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U.S. Department of Health and Human Services

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

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EQUASHIELD LLC EQUASHIELD SYRINGE CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM Back to Search Results
Lot Number 202040
Device Problems Break (1069); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  No Answer Provided  
Event Description
We came across a defective equashield syringe today. The plunger was broken and kept coming out without being connected to the adapter. It has not been contaminated with any medication inside but was just opened. The lot number is 202040 unit 3. Fda safety report id # (b)(4).
 
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Brand NameEQUASHIELD SYRINGE
Type of DeviceCLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
Manufacturer (Section D)
EQUASHIELD LLC
MDR Report Key11462962
MDR Text Key239701183
Report NumberMW5099945
Device Sequence Number1
Product Code ONB
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number202040
Was Device Available for Evaluation? 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?
Type of Device Usage

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