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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXA CORP EXACTAMIX EVA BAG 250ML
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BAXA CORP EXACTAMIX EVA BAG 250ML Back to Search Results
Catalog Number H938737
Device Problem Particulates (1451)
Patient Problem No Patient Involvement (2645)
Event Date 04/01/2015
Event Type  Injury  
Event Description
Three exactamix bags manufactured by baxter had particulate matter at (b)(6).Two bags last week and 1 bag this week were observed with particulate matter by a pharmacy technician upon examination prior to use.The first bag, on the inside filling port that connects to the compounding outlet, there was flaky black substance.This bag is no longer available and the lot number is unknown.On the second bag where the same filling port is, there is a black material in-between the tubing and the plastic that attaches to the compounder.This bag is available for evaluation, from lot 1028470, and is currently empty.With the third bag, the black material is on the outside of the lighter colored plastic piece that connects to the compounder.This bag is also from lot 1028470.This was noticed before there was any patient use.The second and third bags have been returned to baxter for their examination and review.All remaining bags with lot number 1028470 have been sequestered pending investigation by baxter.(b)(4).
 
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Brand Name
EXACTAMIX EVA BAG 250ML
Type of Device
EXACTAMIX EVA BAG 250ML
Manufacturer (Section D)
BAXA CORP
MDR Report Key4752426
MDR Text Key5772536
Report NumberMW5042505
Device Sequence Number3
Product Code NEP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/12/2015
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received05/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberH938737
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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