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

Catalog Number	2C8875
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the tubing of a clearlink system solution set leaked.It was further reported that "three quarter sized puddles under iv pole" was noted.This was identified during patient infusion with etoposide.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3, h4 and h6.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional test including pressure test and clear passage test were performed which revealed a leak due to a hole between white covering and the clear tubing.The reported condition was verified.The cause of the condition is related to a supplier manufacturing issue.This issue is being further investigated.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: DUO-VENT CLEARLINK LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10116597
• Report Number: 1416980-2020-03119
• Device Sequence Number: 14293116
• Product Code: FPA
• UDI-Device Identifier: 00085412046389
• UDI-Public: (01)00085412046389
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: 2C8875
• Device Lot Number: R19J08036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ETOPOSIDE
• Patient Age: 64 YR