PERITX
Report
- Report Number
- 1423507-2025-00119
- Event Type
- Malfunction
- Date Received
- October 29, 2025
- Date of Event
- October 6, 2025
- Report Date
- January 14, 2026
- Manufacturer
- CAREFUSION, INC
- Product Code
- PNG
- UDI-DI
- 10885403500831
- PMA / PMN Number
- SEE H.11.
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H11: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS NOT BEEN RETURNED. PHOTOS WERE NOT PROVIDED. THE INVESTIGATION IS CURRENTLY UNDERWAY. 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
H11: THERE WERE NO PHOTOS PROVIDED FOR REVIEW, AND THE PHYSICAL SAMPLE WAS NOT RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A POTENTIAL CAUSE OF THE FAILURE COULD BE CONTRIBUTED TO USE ERROR, AS PER THE ENTRY DESCRIPTION "DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT AN UNKNOWN MATERIAL WAS CONNECTED BY FORCE, BUT IT IS UNCLEAR WHAT MATERIAL COMPONENTS WERE CONNECTED BY FORCE." A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR PART: 50-9050A LOT: 0001591651 WAS CONDUCTED. NO CONFIRMED QUALITY ISSUES OR REJECTIONS RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED. 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. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITIONS WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. D4 (MEDICAL DEVICE EXPIRATION DATE), G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), ANNEX A (MEDICAL DEVICE PROBLEM CODE), H6 (ANNEX G ¿ COMPONENT CODE), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS). 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 ON (B)(6) 2025, DURING USE OF THE PERITX PERITONEAL CATHETER MINI KIT, THE VALVE WAS DAMAGED BY OTHER UNKNOWN MATERIAL, AND THE SAFETY VALVE WAS FOUND BROKEN / DAMAGED / DISCONNECTED. THE VALVE WAS CHANGED TO RESOLVE THE ISSUE AND DRAINAGE WAS SUCCESSFUL. THERE WERE NO MEDICAL INTERVENTION AND THERE WAS NO EXPOSURE TO BLOOD/BODILY FLUID. NO IMPACT TO THE PATIENT WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT AN UNKNOWN MATERIAL WAS CONNECTED BY FORCE, BUT IT IS UNCLEAR WHAT MATERIAL COMPONENTS WERE CONNECTED BY FORCE. IT WAS CLARIFIED THAT THE VALVE WAS CRACKED BUT IT IS UNKNOWN IF THE VALVE DISCONNECTED. THE PATIENT IS BEING TREATED FOR ASCITES.
IT WAS REPORTED THAT ON (B)(6) 2025, DURING USE OF THE PERITX PERITONEAL CATHETER MINI KIT, THE VALVE WAS DAMAGED BY OTHER UNKNOWN MATERIAL, AND THE SAFETY VALVE WAS FOUND BROKEN / DAMAGED / DISCONNECTED. THE VALVE WAS CHANGED TO RESOLVE THE ISSUE AND DRAINAGE WAS SUCCESSFUL. THERE WERE NO MEDICAL INTERVENTION AND THERE WAS NO EXPOSURE TO BLOOD/BODILY FLUID. NO IMPACT TO THE PATIENT WAS REPORTED. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT AN UNKNOWN MATERIAL WAS CONNECTED BY FORCE, BUT IT IS UNCLEAR WHAT MATERIAL COMPONENTS WERE CONNECTED BY FORCE. IT WAS CLARIFIED THAT THE VALVE WAS CRACKED BUT IT IS UNKNOWN IF THE VALVE DISCONNECTED. THE PATIENT IS BEING TREATED FOR ASCITES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2409214 | PERITX | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING | PNG | CAREFUSION, INC | 0001591651 | 10885403500831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |