MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C8401
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a clearlink solution set leaked from ¿the lower side¿ of the set during setup.There was no patient injury or medical intervention associated with this event.No additional is available.
Additional Manufacturer Narrative
The device was received for evaluation.A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot.A visual inspection was performed with the naked eye and it was noted that the tubing was cut near the chamber port.Functional testing was performed which included underwater leak testing.During leak testing a leak was observed at the location of the cut.Leaks were not observed at other parts of returned sample.The reported condition was verified.An assignable cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• MDR Report Key: 7240843
• Report Number: 1416980-2018-00540
• Device Sequence Number: 19091700
• Product Code: FPA
• UDI-Device Identifier: 00085412048932
• UDI-Public: (01)00085412048932
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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 Expiration Date: 08/25/2022
• Device Catalogue Number: 2C8401
• Device Lot Number: SR17H22070BRK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 01/13/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1