PERITX
Report
- Report Number
- 1423507-2025-00155
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Date of Event
- October 13, 2025
- Report Date
- January 22, 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 WAS NOT PROVIDED; A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. PHOTOS WERE NOT PROVIDED FOR REVIEW. THE DEVICE WAS NOT RETURNED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. G4: PMA/510(K): K201155; K241946 D4 (EXPIRATION DATE IS UNKNOWN) H4 (DEVICE MANUFACTURING DATE IS UNKNOWN) 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. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. 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. B5 (DESCRIBE EVENT OR PROBLEM), 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) 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, THE VALVE WAS REMOVED AS IT DETACHED (DOES NOT HOLD, SLIPPED OUT) AND SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED. THE VALVE WAS REPLACED, AND SUCCESSFUL DRAINAGE WAS ACHIEVED. NO MEDICAL INTERVENTION WAS REPORTED. NO REPORTED INJURY WAS REPORTED.
IT WAS REPORTED THAT ON (B)(6) , 2025, THE VALVE WAS REMOVED AS IT DETACHED (DOES NOT HOLD, SLIPPED OUT) AND SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED. THE VALVE WAS REPLACED, AND SUCCESSFUL DRAINAGE WAS ACHIEVED. NO MEDICAL INTERVENTION WAS REPORTED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2813390 | PERITX | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING | PNG | CAREFUSION, INC | UNKNOWN | 10885403500831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |