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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number AZC9697
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This event occurred during an unspecified date of 2021.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that chemotherapy solution leaked through "the connection of the set cup" during use of a solution administration set.This was identified during preparation.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to h4 and h6.H10: 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
SOLUTION ADMINISTRATION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11328638
MDR Text Key232334114
Report Number1416980-2021-00629
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/26/2021
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 Other
Device Catalogue NumberAZC9697
Device Lot NumberPE82P5
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/21/2021
Initial Date FDA Received02/15/2021
Supplement Dates Manufacturer Received03/26/2021
Supplement Dates FDA Received03/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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