MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C8857
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 a vented paclitaxel set leaked from the unspecified location.This issue was noted during 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
Additional information was added to h3, h4 and h6.H10: the actual device was not available; however, a photograph of the sample¿s empty package was provided for evaluation.A visual inspection was performed to the photograph using the naked eye, it was not possible to observe through the picture of the package any defect that could generate the leak.Due to the nature of the returned sample no additional testing could be performed.Therefore, the reported condition was not verified.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 SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10809290
• Report Number: 1416980-2020-06941
• Device Sequence Number: 17179015
• Product Code: FPA
• UDI-Device Identifier: 00085412046372
• UDI-Public: (01)00085412046372
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• PMA/510(K) Number: K160007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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: 2C8857
• Device Lot Number: R19C30075
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1