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

Catalog Number	2H8401
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
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of clearlink system non-dehp solution sets leaked from the tubing.The leak was discovered during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information : the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed according to product specifications.Functional testing including pressure and clear passage tests were performed which revealed a hole in the tubing.The reported condition was verified.The cause of the condition was due to production during manufacturing.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: 8520395
• Report Number: 1416980-2019-02062
• Device Sequence Number: 1515357
• Product Code: FPA
• UDI-Device Identifier: 00085412049090
• UDI-Public: (01)00085412049090
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: Other
• Device Catalogue Number: 2H8401
• Device Lot Number: R18F26051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1