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

Catalog Number	2C8546
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of a clearlink continu-flo solution set was indented, and had brown foreign matter in the indentation.This was identified prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed to the photograph and a particulate matter (pm) was observed inside the tubing due to a degraded piece of burned plastic inside the tubing.The reported condition was verified.The cause of the condition was not determined.Furthermore, no cut, slice or hole was observed via the photograph.Due to the nature of the reported problem no additional testing could be performed.Therefore, the reported indentation could not be verified 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 SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9445387
• Report Number: 1416980-2019-06792
• Device Sequence Number: 13959642
• Product Code: FPA
• UDI-Device Identifier: 00085412048987
• UDI-Public: (01)00085412048987
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K961225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 2C8546
• Device Lot Number: R19H11017
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1