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

Catalog Number	2H8519
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that one hundred nineteen (119) clearlink system non-dehp continu-flo solution sets had ¿blurred labeling print¿.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
One-hundred-twenty-three (123) actual samples received for evaluation.Visual inspection was performed using the naked eye which observed transfer ink in all samples and some parts were illegible.The reported condition was verified.The cause of the condition was not determined; however, this ink is water base, therefore, contact with other liquid can occasioned this failure mode.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The actual devices were not available; however, photographs of two (2) the samples were provided for evaluation.The returned photographs were reviewed, and it was noted that the ink on the label was smeared.The ink used to print the labeling is water based, therefore, it is known that contact with other liquid can cause the ink to be smeared/removed.The reported condition was verified for the two (2) photographed samples.The cause of the reported condition is the cleaning products that were used by the customer to wipe the packaging.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: 10525868
• Report Number: 1416980-2020-05646
• Device Sequence Number: 14232582
• Product Code: FPA
• UDI-Device Identifier: 00085412048451
• UDI-Public: (01)00085412048451
• Combination Product (Y/N): Y
• Initial Reporter Country: PE
• PMA/510(K) Number: K961225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2020

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: 2H8519
• Device Lot Number: R20C28092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 12/15/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/16/2020; 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1