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

Catalog Number	2H8631
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 clearlink system non-dehp extension set leaked from the intravenous (iv) port.This issue was identified during priming.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information : the device was received for evaluation.A visual inspection was performed and the tubing observed was twisted inside the second y-site.A functional testing was performed including pressure test and clear passage test which revealed a leak coming from the twisted tubing.The reported condition was verified.The cause of the condition was due to machine error during the manufacturing process.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 LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8888170
• Report Number: 1416980-2019-04407
• Device Sequence Number: 10846638
• Product Code: FPA
• UDI-Device Identifier: 00085412080949
• UDI-Public: (01)00085412080949
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K112893
• 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): 09/11/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2H8631
• Device Lot Number: R18I28036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1