MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; STOPCOCK, I.V. SET

Catalog Number 2C6255

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink system continu-flo solution set leaked from the connection site.This was identified during use.There was no patient injury or medical intervention associated with this event.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.All components were correctly placed and according to specifications.Functional testing including pressure testing and clear passage testing was performed with no issues noted.The reported condition was not verified.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 CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10845146
• MDR Text Key: 216416194
• Report Number: 1416980-2020-07143
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00085412046310
• UDI-Public: (01)00085412046310
• Combination Product (y/n): Y
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

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
• Device Operator: Other
• Device Catalogue Number: 2C6255
• Device Lot Number: R20F25075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1