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

Catalog Number	2N8377
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
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 clearlink system non-dehp y-type catheter extension set disconnected while in use, which resulted in blood loss.The disconnection was further described as the set completely coming apart while the patient was connected.The product was in use and connected to the patient for an unspecified number of hours, from pre-op, intra-op, and post-op, before the disconnection occurred.The amount of blood lost was unspecified.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation contaminated with blood.During visual examination, the disconnection was observed between the tubing and the y-junction.A lack of solvent around the circumference of the tube was noted.No further testing could be performed due to contamination.The reported condition was verified; however, the cause of the condition could not be determined.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: 7291833
• Report Number: 1416980-2018-00978
• Device Sequence Number: 11029681
• Product Code: FPA
• UDI-Device Identifier: 00085412051314
• UDI-Public: (01)00085412051314
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: 07/18/2022
• Device Catalogue Number: 2N8377
• Device Lot Number: R17G18032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/23/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1