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

Catalog Number	2N8378
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 system non-dehp catheter extension sets had crack in the tubing where the larger more rigid tubing downsizes to the standard diameter tubing junction.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
An actual device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A magnified inspection identified solvent voids around the tubing inserted on the two piece luer lock.The tubing was measured and found to be between the tolerance range.Functional testing including clear passage and pressure tests were performed and revealed a leak between the tubing and the two piece luer lock assembly.The reported condition was verified.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 - AIBONITO; aibonito
• MDR Report Key: 8142404
• Report Number: 1416980-2018-07676
• Device Sequence Number: 16196903
• Product Code: FPA
• UDI-Device Identifier: 00085412048918
• UDI-Public: (01)00085412048918
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2019

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: Other
• Device Expiration Date: 06/14/2023
• Device Catalogue Number: 2N8378
• Device Lot Number: UR18F14024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1