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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number VMC0172P
Device Problem Melted (1385)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This occurred on an unspecified date in (b)(6) 2021.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the tubing of a buretrol solution administration set ¿looks melted¿.This was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed that the tubing was damaged.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
BURETROL SOLUTION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11334310
MDR Text Key232170091
Report Number1416980-2021-00680
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 03/19/2021
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 Other
Device Catalogue NumberVMC0172P
Device Lot Number20C25T886
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2021
Initial Date Manufacturer Received 01/22/2021
Initial Date FDA Received02/16/2021
Supplement Dates Manufacturer Received03/18/2021
Supplement Dates FDA Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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