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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 250 ML TPN BAG; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION 250 ML TPN BAG; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938737
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Manufacturing facility - the devices were manufactured at one of the two following manufacturing sites: (b)(4).The devices were discarded and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that foreign substance was observed in four (4) 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags.This issue was identified prior to treatment.There was no patient involvement.No additional information is available.
 
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Brand Name
250 ML TPN BAG
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
see h10
see h10
see h10
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10454569
MDR Text Key204393617
Report Number1416980-2020-05200
Device Sequence Number1
Product Code LHI
Combination Product (y/n)Y
Reporter Country CodeTW
PMA/PMN Number
K900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberH938737
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/03/2020
Initial Date FDA Received08/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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