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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO TUR IRRIGATION SET; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE - CARTAGO TUR IRRIGATION SET; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number 2C4041
Device Problems Failure to Prime (1492); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
This report summarizes 1 malfunction events.It was reported that a y-type tur/bladder irrigation set did not prime properly.The tube was reported to be kinked.This occurred during priming.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The single-use sample was received for evaluation.A visual inspection was performed and noted all components were correctly placed according to specification.Functional testing was performed with no issues noted.The reported issue was not verified.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.
 
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Brand Name
TUR IRRIGATION SET
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE - CARTAGO
cartago
MDR Report Key8556980
MDR Text Key144885372
Report Number1416980-2019-02329
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 07/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number2C4041
Device Lot NumberR18C12082
Initial Date Manufacturer Received 03/31/2019
Initial Date FDA Received04/26/2019
Supplement Dates Manufacturer Received06/30/2019
Supplement Dates FDA Received07/29/2019
Patient Sequence Number1
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