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

Catalog Number 2C8607

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the stopcock of an unspecified quantity of clearlink system extension sets with 4-way large bore stopcocks pop off and leak.This was further described as, these are extension tubings they are hooking up to patients before their procedure.These are procedures done only on adults.It was stated ¿they sometimes leak at where the stopcock attaches to the baxter extension tubing¿ of the set.This issue was identified during setup and preparation prior to performing the procedure.There was no report of patient injury or medical intervention associated with this event.

• Brand Name: CLEARLINK STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12360725
• MDR Text Key: 267913659
• Report Number: 1416980-2021-05199
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8607
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2021
• 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