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 01/29/2024

Event Type  malfunction  

Event Description

It was reported that the tubing adjacent to the luer valve, below the roller clamp of a clearlink system continu-flo solution set was observed separated.The event occurred when the drug/tubing was removed from the transport bag while in the pharmacy.The tubing was immediately noticed to be in two pieces.The tubing was clamped and the solution did not leak out.There was no patient involvement.No additional information is available.

Manufacturer Narrative

E1: initial reporter address: (b)(6).E1: initial reporter phone no: (b)(6).G1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: d4, h3, h4, h6, h10 h10: the actual device was not available; however, a photograph of the actual sample and a companion sample were provided for evaluation.A visual inspection of the photograph identified the tubing was separated from the clearlink in the upstream part.Visual inspection was performed o the companion sample and no defects were observed that could have contributed to the reported condition.Functional (pressure, clear passage, pull) testing along with priming were performed and no issues were noted.The reported condition was verified on the actual sample; however, the reported condition was not verified on the companion sample.The cause of the separation could not be determined.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 - CARTAGO; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18769034
• MDR Text Key: 336196538
• Report Number: 1416980-2024-00727
• Device Sequence Number: 1
• Product Code: FPA
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8537
• Device Lot Number: R23J30048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2023
• 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: NA.