PLEURX PLEURAL CATHETER AND STARTER KIT
Received May 27, 2026 · Event occurred Apr 29, 2026
Report 1423507-2026-00075 · MDR key 25303211
Device
Generic name
Apparatus, Suction, Patient Care
Manufacturer
Carefusion, IncCatalog number
50-7700
Lot number
RELN3278
Product problems
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. PHOTOS WERE PROVIDED FOR REVIEW. PHOTO REVIEW IS UNDER WAY. THE INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2026, THE PLEURX LOCKABLE DRAINAGE LINE TUBING BECAME DISCONNECTED FROM THE LUER LOCK TO CONNECT TO THE CATHETER. A NEW TRAY WAS OPENED TO COMPLETE THE PROCEDURE. NO IMPACT TO THE PATIENT WAS REPORTED.