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

Catalog Number 2R8480

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/16/2022

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink, non-dehp solution set leaked at the connection between the tubing and drip chamber.The issue was identified during use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed including clear passage and pressure testing which revealed a leak between the assembly of the tubing into the drip chamber.The assembly of the tubing into the drip chamber is according to specifications.Additional priming was performed at the set with sterile water which revealed a leak in the affected area.Dimensional testing was performed at the tubing and no issues observed.The reported condition was verified.The cause of the condition was due to improper manual assembly during the manufacturing process.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15227662
• MDR Text Key: 302331395
• Report Number: 1416980-2022-04233
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K153158
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2R8480
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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