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

Catalog Number	2C6256
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
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
This report summarizes 7 malfunction events.It was reported that seven (7) clearlink continu-flo solution sets leaked "near the cap''.This occurred during infusion.The events involved a patient with no patient consequences.No additional information is available.
Additional Manufacturer Narrative
Three samples were received for evaluation.The returned units were labeled for single use.A visual inspection was performed on all three samples and all components were noted to be correctly placed and met device specifications.Pressure and functional testing were performed and a leak from the tubing was identified in one of the samples.The cause of the leak was determined to be a small cut in the tubing.The reported condition was verified for the one sample.The cause of the small cut in the tubing could not be determined.The remaining two samples were determined to be conforming products as no leaks were noted during functional and pressure leak testing.The reported condition was not verified for two 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: CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina, san cristobal
• MDR Report Key: 8547295
• Report Number: 1416980-2019-02211
• Device Sequence Number: 11373417
• Product Code: FMG
• UDI-Device Identifier: 00085412073682
• UDI-Public: (01)00085412073682
• Combination Product (Y/N): N
• Number of Events Summarized: 7
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

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?: No
• Operator of Device: No Information
• Device Catalogue Number: 2C6256
• Device Lot Number: DR18K21046
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/29/2019
• Patient Sequence Number: 1