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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 ARC7503P
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The actual device was not available; however, a photograph of the sample was provided for evaluation. Visual inspection observed particles inside the chamber of the set. The reported condition was verified. The cause of the condition was not determined. A nonconformance has been opened to address this issue. 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.
 
Event Description
It was reported that an unspecified quantity of buretrol solution sets had particulate matter inside the fluid path. This was identified prior to patient use. There was no patient involvement. No additional information is available.
 
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Brand NameBURETROL SOLUTION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CALI
calle 36 no. 2c-22
apartado aero 2446
cali
CO
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key11089152
MDR Text Key224279387
Report Number1416980-2020-08149
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412479484
UDI-Public(01)00085412479484
Combination Product (y/n)Y
Reporter Country CodePE
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberARC7503P
Device Lot NumberSE20EL1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2020
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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