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

Catalog Number 2R8486

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 11/24/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a clearlink non-dehp solution set had a hole about 1.5 inches long in the middle of the tubing.This was observed during priming.The total parenteral nutrition (tpn) containing tube leaked though the clamp and cap was on the set.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was provided for evaluation.A visual inspection with the naked eye observed a cut in the tubing.The reported condition was verified.The cause of the condition was a manufacturing related issue.It was determined the set was placed incorrectly in the pouch prior to packaging, leaving parts of the set outside the pouch and exposed to the packaging machine blades causing the cut in 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 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: 18331138
• MDR Text Key: 330956114
• Report Number: 1416980-2023-06547
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412565675
• UDI-Public: (01)00085412565675
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2R8486
• Device Lot Number: R23F01109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• 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.