THORA/PARA TRAY, 5FR, NON-VALVED
Received Jun 19, 2026 · Event occurred May 24, 2026
Report 1423507-2026-00090 · MDR key 25563103
Device
Product problems
- Fluid/Blood Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H11: H11: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS NOT BEEN RETURNED. PHOTOS HAVE NOT BEEN PROVIDED FOR REVIEW. 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, AFTER THE CATHETER WAS INSERTED INTO THE ABDOMEN, WHEN THE TUBING WAS CONNECTED TO THE CATHETER AND DRAINAGE PLASTIC COLLECTION CONTAINER FLUID, THERE WAS NO DRAIN TO VACUUM. A GLASS COLLECTION CONTAINER WAS ALSO USED WITH THE SAME RESULT; WHEN THE TUBING WAS DISCONNECTED FROM THE CATHETER FLUID CONTINUED TO LEAK OUT. THE HEALTH CARE PROVIDER WAS ABLE TO PULL FLUID OFF CATHETER WITH SYRINGE. NO PATIENT HARM WAS REPORTED.