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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - SINGAPORE CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number JC8386
Device Problem Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The sample was received for evaluation. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. During visual inspection it was observed that the tubing had a transverse cut. The reported condition was verified. The cause was due to human error during the manufacturing process. Actions taken were implemented after the lot was manufactured and are currently in place and running at manufacturing process for this product family to mitigate and detect the condition. The product reported in this record was manufactured prior to the implementation of the improvements and therefore was not subjected to these measures. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the tubing of a clearlink system continu-flo set was cut inside its intact packaging. This was noted before use. There was no patient involvement. No additional information is available.
 
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Brand NameCLEARLINK CONTINU-FLO SOLUTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - SINGAPORE
singapore
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park d
street 2
singapore 73875 0
SN 738750
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7000085
MDR Text Key104082671
Report Number1416980-2017-08762
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
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 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberJC8386
Device Lot NumberDR17D01043
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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