PERITX PERITONEAL CATHETER & STARTER KIT
Report
- Report Number
- 1423507-2025-00088
- Event Type
- Malfunction
- Date Received
- October 6, 2025
- Date of Event
- September 9, 2025
- Report Date
- December 24, 2025
- Manufacturer
- CAREFUSION, INC
- Product Code
- PNG
- UDI-DI
- 10885403501838
- PMA / PMN Number
- SEE H.11.
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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/510K: 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.
H11: TWO PHOTOS SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR EVALUATION. WE CAN CONFIRM THAT THE INCORRECT CARTON IS PRESENT. THE PRODUCT WAS PACKAGED INTO THE INCORRECT CARTON; THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER REKU0292 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. BASED ON THE QUALITY TEAM'S INVESTIGATION, IT WAS IDENTIFIED THAT THE PROBABLE ROOT CAUSE IS TRACED TO MANUFACTURING RELATED. A FORMAL INVESTIGATION WAS OPENED TO FURTHER INVESTIGATE THESE DEFECTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H6: ANNEX G (COMPONENT CODE), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS), E1(CONTACT INFORMATION). 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.
IT WAS REPORTED THAT THE CUSTOMER ORDERED ITEM 50-9900C (PERITX PRODUCT) BUT RECEIVED THREE UNITS PACKAGED IN PLEURX BOXES. THE ISSUE WAS DETECTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. BASED ON THE FOLLOW-UP, IT WAS FURTHER REPORTED THAT THE PRODUCT INSIDE THE PACKAGING IS THE CORRECT PERITX PERITONEAL CATHETER KIT, AND ONLY THE OUTER BOX IS INCORRECT.
IT WAS REPORTED THAT THE CUSTOMER ORDERED ITEM 50-9900C (PERITX PRODUCT) BUT RECEIVED THREE UNITS PACKAGED IN PLEURX BOXES. THE ISSUE WAS DETECTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. BASED ON THE FOLLOW-UP, IT WAS FURTHER REPORTED THAT THE PRODUCT INSIDE THE PACKAGING IS THE CORRECT PERITX PERITONEAL CATHETER KIT, AND ONLY THE OUTER BOX IS INCORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2488315 | PERITX PERITONEAL CATHETER & STARTER KIT | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING | PNG | CAREFUSION, INC | REKU0292 | 10885403501838 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |