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

Catalog Number ASKU

Device Problem Filling Problem (1233)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that an unspecified one link under infused while connected to a large volume infusor.It was further reported, after the expected infusion time of 96 hours of infusion, ¿a lot of drug¿ remained in the device.The device was filled with 5-fluorouracil and infused via a peripherally inserted central catheter (picc).This was observed after use of the device.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph was provided for evaluation.Visual inspection of the photograph revealed that there was a device attached to the infusor; however, it was not possible to determine if the device was a one-link due to the quality of the photograph.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12933910
• MDR Text Key: 281852277
• Report Number: 1416980-2021-07134
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: No
• 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: FLUOROURACIL; INFUSOR; PICC LINE