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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIX2VIAL FILTER TRANSFER SET; SET, I.V, FLUID TRANSFER

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MIX2VIAL FILTER TRANSFER SET; SET, I.V, FLUID TRANSFER Back to Search Results
Device Problems Disconnection (1171); Entrapment of Device (1212)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Mix 2 vial filter transfer set malfunctioned after mixing kcentra with sterile water.The luer tip remained lodged into the blue cap of the transfer set and disconnected from the clear cap.Medication was unable to be drawn up since the tip of the transfer set was lodged into the blue cap.
 
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Brand Name
MIX2VIAL FILTER TRANSFER SET
Type of Device
SET, I.V, FLUID TRANSFER
MDR Report Key9552621
MDR Text Key173950754
Report NumberMW5092032
Device Sequence Number1
Product Code LHI
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
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