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

Catalog Number	2C6425
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/13/2020
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 there was particulate matter in 10 solution sets.This was identified prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h3, h4 and h6.Correction to the previously submitted b5.The corrected quantity of the affected products is two (2), previously submitted as ten (10).H10: two (2) actual samples were received for evaluation.Visual inspection was performed using the naked eye which did not identify particulate matter inside the sets.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: INTERLINK SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10382251
• Report Number: 1416980-2020-04814
• Device Sequence Number: 19625228
• Product Code: FPA
• UDI-Device Identifier: 00085412002149
• UDI-Public: (01)00085412002149
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2020

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: 2C6425
• Device Lot Number: R17A08010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1