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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 Problem Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the filter of a vented paclitaxel set was torn.This was identified during setup and preparation.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d10, h3 and h6.H10: the device was received for evaluation.A visual inspection was performed and observed that the filter was damaged.No functional testing was performed for this complaint.The reported condition was verified.The cause of the condition is related to a supplier manufacturing issue.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 Key10226687
MDR Text Key197786405
Report Number1416980-2020-03742
Device Sequence Number1
Product Code FPA
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 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVMC9627
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2020
Initial Date Manufacturer Received 06/09/2020
Initial Date FDA Received07/02/2020
Supplement Dates Manufacturer Received07/28/2020
Supplement Dates FDA Received08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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