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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE CLEARLINK SECONDARY MEDICATION SET SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - SINGAPORE CLEARLINK SECONDARY MEDICATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C7461
Device Problems Fluid Leak (1250); Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2018
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation. Visual inspection revealed that the spike shaft was damaged/cut. Due to the condition of the returned sample, no further testing was performed. The reported condition was verified. The cause of the condition was not determined. 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.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a clearlink secondary medication set had a ¿cut to the spike¿, which resulted in chemotherapy leaking from the area. It was not specified when in the process this occurred. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameCLEARLINK SECONDARY MEDICATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - SINGAPORE
singapore
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park d
singapore 73875 0
SN 738750
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7212667
MDR Text Key104295820
Report Number1416980-2018-00326
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C7461
Device Lot NumberSR17G24035
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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