MAUDE Adverse Event Report: CareFusion, Inc PLEURX PLEURAL CATHETER MINI KIT; apparatus, suction, patient care

Catalog Number	50-7050
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction

• Brand Name: PLEURX PLEURAL CATHETER MINI KIT
• Common Device Name: apparatus, suction, patient care
• Manufacturer (Section D): CareFusion, Inc; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CareFusion, Inc; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: michael gaffney ; 75 n. fairview drive; vernon hills, IL 60061 ; +1(801)565-2341
• MDR Report Key: 50951863
• Report Number: 1423507-2026-00293
• Device Sequence Number: 9624567
• Product Code: DWM
• UDI-Device Identifier: 10885403075988
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K160450
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 50-7050
• Device Lot Number: 0001596508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown