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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Therapy dates ¿ this event occurred on an unspecified date in (b)(6) 2018.(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 the blue slide clamp punctured the tubing of a clearlink solution set when the tubing was being inserted into an unspecified baxter infusion pump.This occurred during infusion, and led to a leak of an unspecified chemotherapy drug.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: 7245516
• Report Number: 1416980-2018-00582
• Device Sequence Number: 1028431
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2018

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: 01/16/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1