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

Catalog Number	3C0157
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/24/2020
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 clealink system buretrol solution set appeared tampered with.The contents of the box were repackaged in a different box and the label was also moved to the new box.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph which observed a box that was not labelled as baxter and some units were seen inside the box.The reported condition was verified.This condition is not generated at the manufacturing facility.A notification was sent to the distribution center.Due to the nature of the returned sample no additional testing could be performed.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 BURETROL SOLUTION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9856296
• Report Number: 1416980-2020-01555
• Device Sequence Number: 2611316
• Product Code: FPA
• UDI-Device Identifier: 00085412073415
• UDI-Public: (01)00085412073415
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123874
• 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): 04/17/2020

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: 3C0157
• Device Lot Number: DR19J12020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1