PLEURX DRAINAGE KIT 1000ML
Report
- Report Number
- 1423507-2025-00097
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- September 16, 2025
- Report Date
- December 29, 2025
- Manufacturer
- CAREFUSION, INC
- Product Code
- DWM
- UDI-DI
- 10885403090707
- 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 PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. ONE PHOTO WAS PROVIDED FOR REVIEW. DURING THE PHOTO REVIEW PROCESS, THE IMAGE PROVIDED BY THE CUSTOMER SHOWED A SLIGHT REDDISH/WHITISH DISCOLORATION INSIDE THE DRAINAGE TUBING, WHICH IS CONSISTENT WITH BODILY FLUIDS (BLOOD MIXED WITH LIPIDS OR PROTEINS) AND CAN OCCUR DURING THE INITIAL PLEURAL DRAINAGE PROCESS OR DUE TO THE PATIENT¿S CONDITION AND DIET. NO SOLID PARTICLES OR SIGNS OF EXTERNAL CONTAMINATION WERE IDENTIFIED. THE INVESTIGATION IS INCONCLUSIVE AS THE REPORTED CONDITION DOES NOT INDICATE PRODUCT CONTAMINATION OR A MANUFACTURING DEFECT. A PROBABLE ROOT CAUSE COULD NOT BE ESTABLISHED BASED ON THE PROVIDED INFORMATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORD AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001606058 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 FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. D2B: PROCODE: DWM; PNG, G3 (DATE RECEIVED BY MANUFACTURER), G4: PMA/510(K)#: K160437; K160450; K201155; K241946, 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.
H11: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. A PHOTO WAS PROVIDED AND REVIEW IS UNDERWAY. THE INVESTIGATION IS CURRENTLY UNDERWAY. H3 (DEVICE EVAL BY MANUFACTURER) A DEVICE HAS NOT BEEN RETURNED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D2B: PROCODE: DWM; PNG G4: PMA / 510(K)#: K160437; K160450; 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.
IT WAS REPORTED THAT DURING AN ATTEMPT TO USE THE PLEURX DRAINAGE KIT BY END USER/LAY PERSON AT HOME, THE BOTTLE WAS FOUND CONTAMINATED AS IT APPEARED TO ALREADY HAVE BEEN USED. THE ISSUE WAS RESOLVED BY REPLACING THE BOTTLE WITH A NEW ONE. THE PATIENT WAS SUCCESSFULLY DRAINED, AND NO PATIENT INJURY WAS REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT EXPOSURE TO BLOOD/BODILY FLUID.
IT WAS REPORTED THAT DURING AN ATTEMPT TO USE THE PLEURX DRAINAGE KIT BY END USER / LAY PERSON AT HOME, THE BOTTLE WAS FOUND CONTAMINATED AS IT APPEARED TO ALREADY HAVE BEEN USED. THE ISSUE WAS RESOLVED BY REPLACING THE BOTTLE WITH A NEW ONE. THE PATIENT WAS SUCCESSFULLY DRAINED, AND NO PATIENT INJURY WAS REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS NOT EXPOSURE TO BLOOD / BODILY FLUID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183158 | PLEURX DRAINAGE KIT 1000ML | APPARATUS, SUCTION, PATIENT CARE | DWM | CAREFUSION, INC | 0001606058 | 10885403090707 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |