MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C6254
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of clearlink system continu-flo solution sets had leaking issues.It was further reported that the leaks occurred where the t-connector attached to the actual iv catheter.This issue was identified during an unspecified process step.There was no report of patient injury, or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation.The visual evaluation to the unit contained in the packaging could not be performed due to the angle of the picture.No additional testing could be performed due to the nature of the sample.The reported condition therefore could not be confirmed or refuted.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.

• Brand Name: CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10839909
• Report Number: 1416980-2020-07118
• Device Sequence Number: 11806694
• Product Code: FPA
• UDI-Device Identifier: 00085412046303
• UDI-Public: (01)00085412046303
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K130245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 2C6254
• Device Lot Number: DR20G02064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1