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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CALI CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - CALI CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number MRC1007P
Device Problems Fluid Leak (1250); Material Rupture (1546); Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 09/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. As the sample was not returned and the lot number is unknown, a device analysis cannot be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the clearlink valve ruptured which resulted in a leak. It was further reported the device "cut appears to look burnt" and ruptured in the administration line; therefore, the device leaked. The event occurred during priming with an unspecified solution. There was no patient involvement. No additional information is available.
 
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Brand NameCLEARLINK LUER ACTIVATED VALVE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - CALI
cali
Manufacturer (Section G)
BAXTER HEALTHCARE - CALI
calle 36 no. 2c-22
apartado aero 2446
cali
CO
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5998944
MDR Text Key56446290
Report Number1416980-2016-15936
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,consum
Reporter Occupation
Type of Report Initial
Report Date 10/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMRC1007P
Device Lot NumberSE16FQ9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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