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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 Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This event occurred between (b)(6) 2020 to (b)(6) 2020.(b)(6).The lot was manufactured between october 16, 2019 to october 17, 2019.The device was received for evaluation.Unaided visual inspection was performed which observed a damaged thread area of the fill port cap.The reported condition was verified.The cause of the condition was not 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.
 
Event Description
During evaluation a 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was found to have a damaged thread area of the fill port cap.This was identified before use.There was no patient involvement.No additional information is available.
 
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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
Manufacturer (Section G)
AVAILMED
c. industrial lt. 001 mz. 105
no 20905 int a, col cd ind.
tijuana, baja california 22444
MX   22444
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10806810
MDR Text Key215278039
Report Number1416980-2020-06912
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412477220
UDI-Public(01)00085412477220
Combination Product (y/n)Y
Reporter Country CodeKS
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 11/06/2020
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 Health Professional
Device Expiration Date09/30/2022
Device Catalogue NumberH938738
Device Lot Number60210025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/13/2020
Initial Date FDA Received11/08/2020
Was Device Evaluated by Manufacturer? Yes
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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