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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - SINGAPORE CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8401
Device Problem Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the tubing of a clearlink solution set was cut in two pieces. This was noted before use. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation. Visual inspection revealed that the tubing was cut in half. 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.
 
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Brand NameCLEARLINK LUER ACTIVATED VALVE
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 Key7341617
MDR Text Key102490602
Report Number1416980-2018-01365
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K112893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 04/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C8401
Device Lot NumberSR17H22070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2018
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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