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

Catalog Number 2R8875

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system, solution set leaked at the white crimps.This issue was identified during priming prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, 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 testing including pressure testing and clear passage testing was performed which revealed a leak between white covering and the tubing.The reported condition was verified.The cause of the reported condition was incorrect assembly during the manufacturing process.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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11147936
• MDR Text Key: 226274445
• Report Number: 1416980-2020-08426
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412565637
• UDI-Public: (01)00085412565637
• Combination Product (y/n): Y
• PMA/PMN Number: K180739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2R8875
• Device Lot Number: R20G22088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1