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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CALI IVT DISPOSABLE; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
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BAXTER HEALTHCARE - CALI IVT DISPOSABLE; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER Back to Search Results
Catalog Number MRD2926P
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2014
Event Type  malfunction  
Event Description
It was reported that a cystoflo drainage bag leaked.This occurred during patient use.There was no report of patient injury, medical intervention or adverse event associated with this event.No additional information is available.
 
Manufacturer Narrative
Complaint no: (b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
IVT DISPOSABLE
Type of Device
COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
Manufacturer (Section D)
BAXTER HEALTHCARE - CALI
apartado aereo 2446
calle #36
cali
CO 
Manufacturer (Section G)
BAXTER HEALTHCARE - CALI
apartado aereo 2446
calle #36
cali
CO  
Manufacturer Contact
christina arnt
25212 w. illinois route 120
round lake, IL 60073
2242703198
MDR Report Key4280925
MDR Text Key5008174
Report Number1416980-2014-42670
Device Sequence Number1
Product Code KNX
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMRD2926P
Was Device Available for Evaluation? No
Date Manufacturer Received10/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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