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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 AZC7525
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This event occurred during the unspecified date of year 2019. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the sterile packaging of two (2) buretrol solution sets presented opened 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 - SAO PAULO
av. alfredo egidio de souza
aranha, 100, bloco c
sao paulo 47261 70
BR 4726170
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9304582
MDR Text Key166835877
Report Number1416980-2019-06230
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
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,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAZC7525
Device Lot NumberPE70S4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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