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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 Problems Disconnection (1171); Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an unspecified access set disconnected from the intravenous (iv) hub and resulted in a leak. This issue occurred during iv vitamin k infusion for an international normalized ratio (inr) of 12. 2. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameNI
Type of DeviceSET, 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 Key12624030
MDR Text Key276163279
Report Number1416980-2021-06235
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/13/2021
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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