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

Catalog Number	2C8612
Medical Device Problem Codes	Disconnection (1171); 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 a ¿bad connector¿ (no further detail) was observed on a clearlink extension set which resulted in a disconnection and a blood leak while in use on a patient.This was further described as a ¿proximal 1¿ male luer ¿connection pops open and blood spills¿.This was identified during ¿the middle¿ of an unspecified patient infusion.The patient noticed the disconnection and alerted the medical staff.The amount of blood loss was reported to be ¿minimal¿.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information : 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: 8692442
• Report Number: 1416980-2019-03225
• Device Sequence Number: 2353918
• Product Code: FPA
• UDI-Device Identifier: 00085412070056
• UDI-Public: (01)00085412070056
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/25/2019

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: R19B02084
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1