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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ATLACOMULCO SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - ATLACOMULCO SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number ABC1499
Device Problems Fluid Leak (1250); Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 11/28/2017
Event Type  malfunction  
Manufacturer Narrative
The device was returned and an evaluation is complete. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Visual inspection was performed and noted that the tube was cut. Retained samples were evaluated with no defects noted. The reported condition was verified. The cause could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was a cut in the middle of the tubing of a solution set. This issue was observed before use while uncoiling the set to begin the prime process. The reporter referred that they did not use scissors or any object that could cut the set. There was no patient involvement. No additional information is available.
 
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Brand NameSOLUTION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - ATLACOMULCO
atlacomulco
Manufacturer (Section G)
BAXTER HEALTHCARE - ATLACOMULCO
av. ing. salvador sanchez
colin no. 9
atlacomulco CP504 50
MX CP50450
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7158159
MDR Text Key104459697
Report Number1416980-2017-10137
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberABC1499
Device Lot Number16YBE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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