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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 500 ML TPN BAG; SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION 500 ML TPN BAG; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938738
Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Patient Problem No Patient Involvement (2645)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was defective.The defect was further described as leak coming from ¿a puncture hole in the middle of the primary sheeting towards the top of the bag¿.This issue was identified after filling and during transportation, prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d4 (lot#), (expiration date), (udi#), d9, h3, h4, and h6.D4: lot #: the lot # is ¿60210023¿, previously submitted as ¿asku¿.D4: expiration date: the expiration date is ¿09/30/2022¿, previously submitted as ¿ni¿.D4: udi #: (b)(4), previously submitted as ¿ni¿.H4: the lot was manufactured from october 11, 2019 ¿ october 15, 2019.H10: the device was received for evaluation.Unaided visual inspection was performed did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed which revealed a leak only on the left side, approximately at the 400 ml area in back of the bag.Additional magnified inspection was performed which verified a tear/hole where the leak occurred.The reported condition was verified.The cause of the condition could not be determined.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.
 
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Brand Name
500 ML TPN BAG
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11340128
MDR Text Key232381094
Report Number1416980-2021-00712
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,health
Type of Report Initial,Followup
Report Date 03/22/2021
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 Expiration Date09/30/2022
Device Catalogue NumberH938738
Device Lot Number60210023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Initial Date Manufacturer Received 01/26/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received03/09/2021
Supplement Dates FDA Received03/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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