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

Catalog Number 2C7558

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name - (b)(6) hospital infusion center g1: device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the filter of a paclitaxel set broke apart from the chamber.This event occurred during the priming process.It was not specified if there was patient involvement.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h3, h4, h6, h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed on the photograph which identified a damaged filter membrane.The reported condition was verified.The cause of the condition could not be determined; however, a probable cause is related to manufacturing.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: INTERLINK 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 60073 ; 2242702068
• MDR Report Key: 18886252
• MDR Text Key: 337465834
• Report Number: 1416980-2024-01073
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412036380
• UDI-Public: (01)00085412036380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C7558
• Device Lot Number: R22J06123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/07/2022
• 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: 0.9% SODIUM CHLORIDE