MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8541

Device Problems Fluid/Blood Leak (1250); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2019

Event Type  malfunction  

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 Description

It was reported that a clearlink duo-vent continu-flo solution set was leaking.It was further reported that the medication was coming out of one of the ports because the ¿valve¿ (of the clearlink port) was missing.This issue was identified during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual sample was received for evaluation.A visual inspection was performed, and it was noted that there was leak at the y-site as the second y-site was not assembled correctly.The reported problem was verified.The cause of the condition was due to manufacturing related 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: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9433717
• MDR Text Key: 169805889
• Report Number: 1416980-2019-06739
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412071107
• UDI-Public: (01)00085412071107
• Combination Product (y/n): N
• PMA/PMN Number: K961225
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8541
• Device Lot Number: R19G08064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1