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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6).Manufacturing facility-this device was manufactured at one of the two following manufacturing sites: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the clamps of an unspecified quantity of 250ml eva 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were misaligned and not working.It was further reported that some of the clamps were chipping and broking upon use.This was identified during setup prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was not returned 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.
 
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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
MDR Report Key10586380
MDR Text Key208536044
Report Number1416980-2020-05972
Device Sequence Number1
Product Code LHI
Combination Product (y/n)Y
PMA/PMN Number
K900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
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
Date Manufacturer Received10/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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