MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C6891

Device Problem Material Rupture (1546)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that thean interlink system extension set with control-a-flo regulator ruptured.This occurred during use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: during follow up, it was clarified that there was no issue with the baxter interlink system extension set.The rupture was caused by fluids being pushed through the dial-a-flow with too much pressure from another tubing that had a bulb on it.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK I.V. ADMINISTRATION SETS WITH CONTROL-A-FLO REGULATOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18504869
• MDR Text Key: 332796721
• Report Number: 1416980-2024-00042
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412002422
• UDI-Public: (01)00085412002422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121634
• 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: 02/06/2024

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: Other
• Device Catalogue Number: 2C6891
• Device Lot Number: DR22D11093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/17/2024
• Supplement Dates FDA Received: 02/06/2024
• 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