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

Catalog Number 2C8537

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that tubing of a clearlink system continu-flo solution set separated at the y-site, below the rolling clamp adjacent to the luer valve.The set was primed with normal saline.This occurred during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H4: the lot was manufactured between january 23, 2024 and january 24, 2024.H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was a separation between the tubing and the second y-site clearlink in the upstream part.A dimensional test was performed to the clearlink y-site housing and tubing which were according to the specification.The reported condition was verified.The cause of the reported condition was improper manual assembly due to a lack of solvent at some areas of the tubing, the solvent was not applied to all the circumference of the tubing.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 SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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 60073 ; 2242702068
• MDR Report Key: 19081022
• MDR Text Key: 339838518
• Report Number: 1416980-2024-01630
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048970
• UDI-Public: (01)00085412048970
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: Other
• Device Catalogue Number: 2C8537
• Device Lot Number: R24A22093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/16/2024
• 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
• Treatment: NORMAL SALINE