PERITX PERITONEAL CATHETER MINI KIT
Received Jun 5, 2026 · Event occurred May 5, 2026
Report 1423507-2026-00081 · MDR key 25412809
Device
Generic name
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Manufacturer
Carefusion, IncCatalog number
50-9050A
Lot number
0001553138
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE VALVE WAS LEAKING DURING USE. THE ISSUE WAS RESOLVED BY REPLACING THE VALVE, AFTER WHICH SUCCESSFUL DRAINAGE WAS ACHIEVED. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION REQUIRED, AND NO IMPACT ON THE PATIENT OR COURSE OF TREATMENT. THE SAFETY VALVE WAS NOTED TO BE DAMAGED. THE PROCEDURE WAS PERFORMED BY AN EWIMED EMPLOYEE AT THE PATIENT¿S HOME, WITH THE CATHETER PLACED IN THE ASCITES POSITION SINCE (B)(6) 2025.
Additional Manufacturer Narrative
H11: A LOT NUMBER WAS PROVIDED SO A DEVICE HISTORY RECORD IS CURRENTLY UNDERWAY. PHOTOS WERE PROVIDED AND REVIEW IS CURRENTLY PENDING. H3 (DEVICE EVAL BY MANUFACTURER) A DEVICE HAS NOT BEEN RETURNED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. G4: PMA/510(K): K201155;K241946. 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.