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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
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BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE Back to Search Results
Device Problems Fitting Problem (2183); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported that a transfer set presented a barely visible bump at the point where the minicap is attached, which interfered with tight seal and allowed iodine to seep out.There was no report of patient injury or medical intervention reported.No additional information is available.
 
Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
(b)(4) as the device was not returned and the lot number was unknown, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Type of Device
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key4868360
MDR Text Key6261371
Report Number1416980-2015-26591
Device Sequence Number1
Product Code KDJ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial
Report Date 06/05/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/11/2015
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 Unknown
Patient Sequence Number1
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