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

Catalog Number 2C6425

Device Problems Backflow (1064); Complete Blockage (1094); Device Dislodged or Dislocated (2923)

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

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported that the gummy stopper (injection port) of an interlink system solution set became dislodged and went into the tubing clogging it.When this occurred, the medication backed up into the iv (intravenous) bag and fluids would not run.The issue was identified while the nurse was injecting medication into the y-port.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Device manufacturer address g1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was received for evaluation.A visual inspection was done which observed a recessed gland in the second y-site interlink.Functional testing including pressure and clear passage tests were performed which revealed blockage in the sample due to the recessed gland.A backflow functional test was performed with an in-lab secondary set which revealed backflow of solution in the device.The reported condition was verified.The cause of the condition was due to a manufacturing assembly issue.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 SET
• 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: 14090803
• MDR Text Key: 289182427
• Report Number: 1416980-2022-01774
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412002149
• UDI-Public: (01)00085412002149
• 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: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C6425
• Device Lot Number: R21F24069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: LACTATED RINGERS SOLUTION
• Patient Sex: Male