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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 VMC9627
Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 01/19/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a long cut was observed on the tubing of a vented paclitaxel set.The long cut resulted in a leak of chemotherapy drug.This was identified during preparation of the chemotherapy drug in the compounding room.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to h3, h4 and h6.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection a cut in the tube was observed.The reported condition was verified.The cause of the condition was due to a human production issue during manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 Key11323085
MDR Text Key232090432
Report Number1416980-2021-00593
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05413760229102
UDI-Public(01)05413760229102
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 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVMC9627
Device Lot Number19L11T734
Was Device Available for Evaluation? No
Date Manufacturer Received03/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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