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

Catalog Number	2H8401
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not received for evaluation; therefore, a device analysis could not be performed.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.This occurred during infusion using an unspecified infusion pump.The issue was noticed when the pump presented an occlusion alarm.When the door of the pump was opened, the set was found to be wet due to the blue slide clamp puncturing the tubing.This led to a leak of approximately 10ml of chemotherapy solution onto the patient¿s skin.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not returned; therefore, a device analysis could not be completed.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: 7218413
• Report Number: 1416980-2018-00368
• Device Sequence Number: 832791
• 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): 02/23/2018

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: 09/12/2022
• Device Catalogue Number: 2H8401
• Device Lot Number: R17I12031
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1