MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8671

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

Medwatch reporter number: mw5097942.Device manufacturer address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of clearlink system extension set separated from the filter.The separation occurred when the nurse was attempting to evacuate an air bubble prior to connecting to the iv for therapy administration.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d10, h3 and h6.H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed that the tubing was separated from the y-site clearlink in the downstream part.The solvent was applied uniformly in the circumference of the tube.However, it was observed that the insertion was not according to specification.Dimensional tests were performed and no issues were noted.The reported condition was verified.The cause of the condition was due to the tail end machine in the automated manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11116604
• MDR Text Key: 225093229
• Report Number: 1416980-2020-08272
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K153158
• 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: 02/04/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 2C8671
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/05/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KEYTRUDA IV INFUSION; KEYTRUDA IV INFUSION