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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number ASKU
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned 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 there was free flow of solution during use of an unspecified access set.This was observed when the set was removed from the unspecified infusion pump without the clamps being closed.The issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
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Brand Name
NI
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
ni
ni
ni
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key15259354
MDR Text Key301759524
Report Number1416980-2022-04342
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received07/25/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NI.
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