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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND IVT DISPOSABLE; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE - CLEVELAND IVT DISPOSABLE; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number 2B8071
Device Problems Detachment Of Device Component (1104); No Flow (2991)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
It was reported that a vial-mate reconstitution device did not flow while connected to a vancomycin bag.In order to mix drug solution into the bag, the user had to detach the vial-mate and perform the mixture manually.This occurred before patient use, so there was no patient involvement.No additional information is available.
 
Manufacturer Narrative
(b)(4).As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
IVT DISPOSABLE
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE - CLEVELAND
911 highway 61 north po box 1
cleveland MS 38732
Manufacturer (Section G)
BAXTER HEALTHCARE - CLEVELAND
911 highway 61 north po box 1
cleveland MS 38732
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key3995403
MDR Text Key21492635
Report Number1416980-2014-25872
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K973654
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2B8071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/16/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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