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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ROUND LAKE SYRINGE INLET, NON-STERILE; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE - ROUND LAKE SYRINGE INLET, NON-STERILE; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938176
Device Problem Partial Blockage (1065)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
This report summarizes 4 malfunction events.It was reported that four (4) syringe inlets were obstructed.The obstructions/occlusions were discovered while producing total parenteral nutrition (tpn) bags prior to patient use.For these events, there was no patient involvement.No additional information is available.
 
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
SYRINGE INLET, NON-STERILE
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE - ROUND LAKE
round lake IL
Manufacturer (Section G)
BAXTER HEALTHCARE - ROUND LAKE
25212 w. illinois route 120
round lake IL 60073
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8555927
MDR Text Key144885743
Report Number1416980-2019-02321
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412475813
UDI-Public(01)00085412475813
Combination Product (y/n)N
Number of Events Reported4
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 07/26/2019
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 No Information
Device Catalogue NumberH938176
Device Lot Number802678
Initial Date Manufacturer Received 03/31/2019
Initial Date FDA Received04/26/2019
Supplement Dates Manufacturer Received06/30/2019
Supplement Dates FDA Received07/26/2019
Type of Device Usage N
Patient Sequence Number1
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