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 Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

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

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an unspecified quantity of clearlink system continu-flo solution sets leaked.It was further stated that ¿where the stopcock is connected was not completely tightened¿.This issue was observed during patient infusions in the pain care center.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to b3, d4:(lot # & udi #), h3, h4, h6 and h10.B3: the event date is (b)(6) 2021, previously submitted ¿asku¿.D4: the lot # is ¿dr21d26048¿, previously submitted as ¿asku¿.D4: the udi # is (b)(4)¿, previously submitted ¿ni¿.H10: the actual devices were not available; however, a companion sample was received for evaluation.Visual inspection was performed using the naked eye did not identify any abnormalities that could have contributed to the reported condition.All components were correctly placed and according to specifications.A functional testing was performed including clear passage and pressure testing; and no leaks or blockage were observed.Additional pull test was performed and no issues noted.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
• 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: 12613892
• MDR Text Key: 275921215
• Report Number: 1416980-2021-06204
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

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: 2C6254
• Device Lot Number: DR21D26048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/12/2021
• Supplement Dates Manufacturer Received: 11/30/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2021
• 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