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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTAMIX INLET NON-VENTED, HIGH-VOLUME INLET SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORP. EXACTAMIX INLET NON-VENTED, HIGH-VOLUME INLET SET, I.V. FLUID TRANSFER Back to Search Results
Lot Number 802523
Device Problems Cap (424); Material Puncture/Hole (1504); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2018
Event Type  Malfunction  
Event Description

Pharmacy tech retrieved baxter exactamix inlet non-vented, high volume inlet, ref: (b)(4), lot: 802523, exp: 12/04/2020. The spike had no cap and pierce the packaging.

 
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Brand NameEXACTAMIX INLET NON-VENTED, HIGH-VOLUME INLET
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
MDR Report Key8129259
MDR Text Key129435365
Report NumberMW5081818
Device Sequence Number1
Product Code LHI
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 11/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date12/04/2020
Device LOT Number802523
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?
Type of Device Usage

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