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

Catalog Number	2C8612
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
The events occurred on unknown dates from (b)(6) 2019.(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 extension sets leaked while in use on patients.The leaks were observed at the hub where the patient¿s angiocatheter and the extension set were connected.The events were observed either preoperatively after the iv was inserted and prior to the patient receiving a regional block, operatively, or postoperatively.Both 20 and 22 gauge angiocatheters were used.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: additional information : the lot was manufactured between february 5, 2018 and february 6, 2018.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 received for evaluation; 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: 8552723
• Report Number: 1416980-2019-02295
• Device Sequence Number: 1730637
• Product Code: FPA
• UDI-Device Identifier: 00085412070056
• UDI-Public: (01)00085412070056
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/28/2019

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: 2C8612
• Device Lot Number: R18B05013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1