PERITX PERITONEAL CATHETER & STARTER KIT
Report
- Report Number
- 1423507-2025-00074
- Event Type
- Malfunction
- Date Received
- October 6, 2025
- Date of Event
- September 10, 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
- PA, 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. B3: DATE OF EVENT: THE DATE OF AWARENESS WAS ENTERED IN THE DATE OF EVENT FIELD AS THE ACTUAL DATE OF EVENT 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: TWO PHOTOS SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR EVALUATION. WE CANNOT CONFIRM THE REPORTED FAILURE OF MISSING COMPONENTS. IN ADDITION, THE COLUMN CONTAINING THE ITEMS MENTIONED IS MISSING FROM THE PROVIDED PHOTO, THE PHOTO DOES NOT INCLUDE THE ENTIRE ARTWORK. 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 AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. 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). 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 PERITX 50-9900C WAS OPENED FOR A PROCEDURE AND WAS MISSING THE TUNNELLER, STIFFENER, AND PEEL-AWAY INTRODUCER. THE PROCEDURE HAD ALREADY BEGUN BEFORE STAFF REALIZED THESE COMPONENTS WERE MISSING. THE PACKAGING DOES NOT HAVE THESE ITEMS LISTED ON THE LABEL. THERE WAS NO REPORTED PATIENT INJURY.
IT WAS REPORTED THAT PERITX 50-9900C WAS OPENED FOR A PROCEDURE AND WAS MISSING THE TUNNELLER, STIFFENER, AND PEEL-AWAY INTRODUCER. THE PROCEDURE HAD ALREADY BEGUN BEFORE STAFF REALIZED THESE COMPONENTS WERE MISSING. THE PACKAGING DOES NOT HAVE THESE ITEMS LISTED ON THE LABEL. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2690887 | 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 |