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

Catalog Number 2C6254

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the connection of an unspecified quantity of clearlink system continu-flo solution sets was "falling apart" resulting in a leak during patient infusion of unknown solution.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photograph was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.Due to the nature of the sample, no additional tests were performed.The reported condition could not be verified during photo inspection.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: 10616505
• MDR Text Key: 209556274
• Report Number: 1416980-2020-06138
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00085412046303
• UDI-Public: (01)00085412046303
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

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: 2C6254
• Device Lot Number: DR20B06082
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/21/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN MEDICATION