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

Catalog Number	2C6425
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred on an unspecified date between the end of (b)(6) 2020 - the beginning of (b)(6) 2020.(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 at least four (4) interlink solution sets were leaking from the proximal port closest to the patient following medication delivery through the port.This issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
H10: the actual devices were not available; therefore a device analysis could not be completed for those samples.However, companion samples were received for evaluation.Visual inspection of a sampling of companion samples did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specifications.Functional testing was performed including clear passage and pressure testing; no issues were noted.The reported condition was not verified on the companion samples.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: 10612266
• Report Number: 1416980-2020-06112
• Device Sequence Number: 3806383
• Product Code: FPA
• UDI-Device Identifier: 00085412002149
• UDI-Public: (01)00085412002149
• Combination Product (Y/N): Y
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: R19D16064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1