PLEURX
Report
- Report Number
- 1625685-2025-00088
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Date of Event
- September 5, 2025
- Report Date
- December 9, 2025
- Manufacturer
- CAREFUSION, INC
- Product Code
- DWM
- UDI-DI
- 10885403075988
- 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: 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 REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. IT WAS CONFIRMED THAT PROCEDURAL AND FUNCTIONAL REQUIREMENTS NEEDED FOR ITS RELEASE WERE MET. COMPLAINTS RECEIVED ABOUT THIS PRODUCT AND CONDITIONS WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. E1(PHONE # AND FAX #), G3 (DATE RECEIVED BY MANUFACTURER), G4: PMA/510K: K141965; K160450, G6 TYPE OR REPORT - FOLLOW UP# 2), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS). INITIAL MDR MFR REPORT # 1625685-2025-00088, SITE LEGAL NAME (FDA) REPORTED, CAREFUSION 2200, INC. - MANNFORD, OK / 74044; SITE REGISTRATION NUMBER (FDA) 1625685. CORRECT SITE LEGAL NAME (FDA) IS, VERNON HILLS; SITE REGISTRATION NUMBER (FDA) 1423507. 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: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE INVESTIGATION IS UNDERWAY. PHOTOS HAVE NOT BEEN RECEIVED FOR REVIEW. THE DEVICE IS PENDING RETURN. THE INVESTIGATION IS CURRENTLY UNDERWAY. B5 (DESCRIBE EVENT OR PROBLEM), D3 (MEDICAL DEVICE MANUFACTURER), G3 (DATE RECEIVED BY MANUFACTURER), G4: PMA/510K: K141965; K160450, G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H6 (ANNEX A - MEDICAL DEVICE PROBLEM CODE). INITIAL MDR MFR REPORT#: 1625685-2025-00088, SITE LEGAL NAME (FDA) REPORTED, CAREFUSION 2200, INC. - MANNFORD, OK / 74044; SITE REGISTRATION NUMBER (FDA) 1625685. CORRECT SITE LEGAL NAME (FDA) IS, VERNON HILLS; SITE REGISTRATION NUMBER (FDA) 1423507. 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: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE INVESTIGATION IS UNDERWAY. PHOTOS HAVE NOT BEEN RECEIVED FOR REVIEW. 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: K141965; K160450. 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 DURING APPLICATION ON (B)(6) 2025, THE PLEURX PLEURAL CATHETER MINI KIT SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED CAUSING A VALVE LEAKAGE. THE ISSUE WAS RESOLVED BY CHANGING THE VALVE. THE PATIENT WAS SUCCESSFULLY DRAINED, AND NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS NOT EXPOSURE TO BLOOD / BODILY FLUID. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE VALVE DID NOT DISCONNECT, BUT IT CRACKED AND LEAKED.
IT WAS REPORTED THAT DURING APPLICATION ON (B)(6) 2025, THE PLEURX PLEURAL CATHETER MINI KIT SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED CAUSING A VALVE LEAKAGE. THE ISSUE WAS RESOLVED BY CHANGING THE VALVE. THE PATIENT WAS SUCCESSFULLY DRAINED, AND NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS NOT EXPOSURE TO BLOOD / BODILY FLUID. DURING FOLLOW UP RESPONSE IT WAS FURTHER REPORTED THAT THE VALVE DID NOT DISCONNECT, BUT IT CRACKED AND LEAKED.
IT WAS REPORTED THAT DURING APPLICATION ON (B)(6) 2025, THE PLEURX PLEURAL CATHETER MINI KIT SAFETY VALVE BROKEN / DAMAGED / DISCONNECTED CAUSING A VALVE LEAKAGE. THE ISSUE WAS RESOLVED BY CHANGING THE VALVE. THE PATIENT WAS SUCCESSFULLY DRAINED, AND NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2111876 | PLEURX | APPARATUS, SUCTION, PATIENT CARE | DWM | CAREFUSION, INC | 0001530049 | 10885403075988 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |