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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 3000 ML TPN BAG; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION 3000 ML TPN BAG; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938741
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a 3000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking from the middle port.The leak was discovered during setup prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to h3, h4 and h6.H4: the lot was manufactured from april 16, 2020 - april 17, 2020.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was evaluated which observed that the spike port binding area that was filled with solution was leaking.The reported condition was verified.The cause of the condition was due to inadequate or lack of cyclohexanone applied to the spike port cap tube when it was inserted to the spike port during the manufacturing process causing an incorrect bonding.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Correction to b2: outcomes attributed to ae ¿ removed ¿congenital anomaly¿ as there was no adverse event or congenital anomaly involved in this report.(previously selected ¿congenital anomaly¿ in error).Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
3000 ML TPN BAG
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10575278
MDR Text Key208191952
Report Number1416980-2020-05923
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412477251
UDI-Public(01)00085412477251
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,consum
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2023
Device Catalogue NumberH938741
Device Lot Number60236618
Was Device Available for Evaluation? No
Date Manufacturer Received10/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NA.
Patient Outcome(s) Congenital Anomaly;
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