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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 Problems Break (1069); Difficult to Open or Close (2921)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The devices were 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.
 
Event Description
It was reported that the clear plastic clip (non-reopening clamp) of an unspecified quantity of 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were difficult to close resulting in breakage.This was identified during preparation of the bags for medication.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information/correction to g1 (address was missing).G1 manufacturing facility - the devices were manufactured at one of the two following manufacturing sites: availmed, c.Industrial lt.001 mz.105, no 20905 int a, col cd ind.Tijuana, baja california, 22444 mexico.Or baxter healthcare - englewood, 14445 grasslands dr, englewood co 80112, united states.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 Key10405312
MDR Text Key202871685
Report Number1416980-2020-04960
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 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
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 Received08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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