MAUDE Adverse Event Report: CLEARLINK CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8537

Device Problems Backflow (1064); Fluid/Blood Leak (1250); Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing facility-this device was manufactured at one of the two following manufacturing sites: baxter healthcare (b)(4) or baxter healthcare (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of tubing of clearlink system continu-flo solution sets were breaking off into a non-baxter extension set.It was further stated that when disconnecting, the male luer breaks off into the female luer of the non-baxter extension set.This resulted in a fluid leak and blood backing up in the intravenous (iv) line.This issue was identified during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

D4: lot #: a suspect lot that was reported was r21d05048.H4: the manufacturing date of the suspect lot r21d05048 was 04/05/2021.A batch review was conducted on the suspect lot and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.Therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12385589
• MDR Text Key: 268725585
• Report Number: 1416980-2021-05309
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• 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: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8537
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BRAUN EXTENSION SETS; UNSPECIFIED FLUID; BRAUN EXTENSION SETS; UNSPECIFIED FLUID