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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION INTERLINK SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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)(6).Eight (8) 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.
 
Event or Problem Description
It was reported that there was particulate matter in eight (8) solution sets; further described as "brown and nasty inside".This was identified prior to patient use.There was no patient involvement.No additional information is available.
 
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Brand Name
INTERLINK SOLUTION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10516412
Report Number1416980-2020-05597
Device Sequence Number11430430
Product Code FPA
UDI-Device Identifier00085412002149
UDI-Public(01)00085412002149
Combination Product (Y/N)Y
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
K961225
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
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 Number2C6425
Device Lot NumberR16I29077
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2020
Initial Report FDA Received Date09/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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