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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address 1:(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that four (4) clearlink system solution sets leaked; further described as when the saline bag was hung, the white plastic that holds the tubing lines together is where it leaked.The devices were used with chemotherapy drugs etoposide and docetaxel.This was identified during setup and preparation.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the actual devices were not available; therefore device analysis could not be completed for those samples.However, ten (10) companion samples were received for evaluation.Visual inspection using the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including pressure and clear passage testing which observed a leak between the white covering and the clear tubing in in 1 sample only.The reported condition was verified in 1 companion sample; however, not verified in 9 companion samples.The cause of the condition was due to improper assembly during manufacturing.A nonconformance has been opened to address this issue.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: 11489562
• Report Number: 1416980-2021-01349
• Device Sequence Number: 17139981
• Product Code: FPA
• UDI-Device Identifier: 00085412046389
• UDI-Public: (01)00085412046389
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2021

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?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1