MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; STOPCOCK, I.V. SET

Catalog Number	3C0062
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
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 an interlink sytem continu-flo solution set came apart at the stopcock which resulted in an intravenous fluid leak.This was observed during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3, h4, h6 and h10.H10: the actual device was not available; however, five (5) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional test including pressure test and clear passage test was performed with no issues were noted.Additionally, priming was performed on the samples with no issues noted.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 CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12844012
• Report Number: 1416980-2021-06867
• Device Sequence Number: 4546879
• Product Code: FMG
• UDI-Device Identifier: 00085412017716
• UDI-Public: (01)00085412017716
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K130245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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: Health Professional
• Device Catalogue Number: 3C0062
• Device Lot Number: R21B25024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRAVENOUS FLUID.
• Patient Sex: Unknown