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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVIA; CONTAINER, I.V.
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BAXTER HEALTHCARE CORPORATION INTRAVIA; CONTAINER, I.V. Back to Search Results
Model Number 2J8003
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2023
Event Type  malfunction  
Event Description
Pharmacist dispensed medication to be drained into an empty intravia 500 ml container.Medication was drained and sent to the cancer center nurse.Nurse called saying that the secondary set was falling out of the fluid bag.Registered nurse (rn) returned medication and secondary set to pharmacy.Upon exam, pharmacist founded secondary set to not be secured and easily removed from port.If rn had hung the medication, it would have spilled on the floor.This port was not touched by pharmacy.
 
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Brand Name
INTRAVIA
Type of Device
CONTAINER, I.V.
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake IL 60073
MDR Report Key17237141
MDR Text Key318215258
Report Number17237141
Device Sequence Number1
Product Code KPE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number2J8003
Device Catalogue Number2J8003
Device Lot NumberDR22K25130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/13/2023
Event Location Outpatient Treatment Facility
Date Report to Manufacturer06/30/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age25915 DA
Patient SexMale
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