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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 ABC2707
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2017
Event Type  malfunction  
Manufacturer Narrative
The actual device was not available; however, a photograph of the sample and reserve samples were provided for evaluation. The defect was observed in the provided photograph. No issues were found with the retention samples. The reported condition was verified; however, the cause of the condition could not be determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. No additional information is available.
 
Event Description
It was reported a solution set leaked. During prime, the solution set leaked due to a hole in the administration line. 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 Key6335856
MDR Text Key67586929
Report Number1416980-2017-01319
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCO
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 02/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/26/2021
Device Catalogue NumberABC2707
Device Lot Number58XHE
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 Received01/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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