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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number EMC5905P
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that three (3) flow regulator sets had fluid leakage located at the flow restrictor. The issue was identified during unspecified process steps before use on a patient. There was no patient involvement. No additional information is available.
 
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Brand NameI.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - TUNISIA
route de chebbaou
2021oued e
tunis
TS
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12557963
MDR Text Key274225907
Report Number1416980-2021-06028
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
NA
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 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEMC5905P
Device Lot Number19A12T043N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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