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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA ALL-IN-ONE CONTAINER SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE - MALTA ALL-IN-ONE CONTAINER SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number RMC3187
Device Problems Cap (424); Disconnection (1171); Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 09/19/2019
Event Type  Malfunction  
Manufacturer Narrative

The device was discarded and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that an eva bag fell to the ground during drug preparation leading to a leak. It was further reported that the blue cap of the bag detached and contents spilled onto the floor. There was no patient involvement. No additional information is available.

 
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Brand NameALL-IN-ONE CONTAINER
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE - MALTA
marsa
Manufacturer (Section G)
BAXTER HEALTHCARE - MALTA
a47 industrial estate
marsa
MT
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9199448
MDR Text Key163199096
Report Number1416980-2019-05641
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberNA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberRMC3187
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2019
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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