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

Catalog Number 2N3378

Device Problem Material Rupture (1546)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an interlink system non-dehp i.V.Catheter extension set leaked.When the tubing was clamped and then the clamp removed, a slight deformity appeared at the site that created a weak point in the tubing.The area ruptured during injection of contrast media.The contrast media was cleaned off the equipment and patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed which showed a part of the set with the tubing and the slide clamp with a dark fluid (blood) and the tubing seemed to be burst or ruptured.The reported condition was verified, however, the product code is intended to be used with a syringe or cannula and is not intended to be used with a power injector; the tubing of this set is not designed for the capacity of that kind of equipment as it is not high pressure tubing.Therefore, the cause of the condition was determined to be use related as it was reported the tubing was being used with a power injector.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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17203700
• MDR Text Key: 318130046
• Report Number: 1416980-2023-03156
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412004938
• UDI-Public: (01)00085412004938
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K925126
• 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: 07/28/2023

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: Health Professional
• Device Catalogue Number: 2N3378
• Device Lot Number: UR18G18056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/23/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2018
• 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: CONTRAST MEDIA