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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 3000 ML TPN BAG SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE ¿ ROUND LAKE 3000 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938741
Device Problems Cap (424); Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

(b)(6) the lot number was manufactured between august 02, 2017 - august 05, 2017. A companion sample was received for evaluation. Visual inspection on the returned sample revealed that the spike port cap was detached from the spike port. No functional testing was performed as during initial inspection the reported condition was verified. The cause of the condition was not determined. This issue is being further investigated. 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 sample evaluation, a spike port cap was detached from the spike port of a 3000 ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag. There was no patient involvement. No additional information is available.

 
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Brand Name3000 ML TPN BAG
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE ¿ ROUND LAKE
round lake IL
Manufacturer (Section G)
BAXTER HEALTHCARE ¿ ROUND LAKE
125212 w. illinois route 120
round lake IL 60073
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8303316
MDR Text Key134974839
Report Number1416980-2019-00577
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeNZ
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 02/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberH938741
Device LOT Number60078408
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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