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Adverse Event Report

BAXTER HEALTHCARE CORP. VIAFLEX CONTAINER, EMPTY. 500 ML   back to search results
Lot Number P048314
Event Description

Three of 6 bags (sterile) are leaking at site between injection site and administration port.

 
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Brand NameVIAFLEX CONTAINER, EMPTY. 500 ML
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BAXTER HEALTHCARE CORP.
deerfield IL 60015
Device Event Key11338
MDR Report Key11338
Event Key7396
Report NumberMW1000645
Device Sequence Number1
Product CodeKPE
Report Source Voluntary
Report Date 01/25/1994
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/01/1994
Is This An Adverse Event Report? No
Device Operator Invalid Data
Device LOT NumberP048314
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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