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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 VMC9607C
Device Problems Filling Problem (1233); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This event occurred during an unspecified date of 2020. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the tubing of a light sensitive drug set was kinked which resulted in a low flow of solution. This was identified during patient use. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameSOLUTION ADMINISTRATION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - TUNISIA
route de chebbaou
2021oued e
tunis
TS
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10570060
MDR Text Key208107845
Report Number1416980-2020-05907
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
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 10/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberVMC9607C
Device Lot Number18J08T178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2018
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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