UNKNOWN PLEURX
Report
- Report Number
- 1625685-2025-00037
- Event Type
- Injury
- Date Received
- April 29, 2025
- Date of Event
- March 19, 2025
- Report Date
- May 9, 2025
- Manufacturer
- CAREFUSION, INC
- Product Code
- PNG
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS HAS NOT BEEN PERFORMED. THE DEVICE WAS NOT RETURNED. THE INVESTIGATION IS CURRENTLY UNDERWAY. H11: 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.
H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. H10: INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. WE ARE UNABLE TO IDENTIFY AN ADVERSE EVENT ASSOCIATED WITH THE PRODUCT THAT WOULD HAVE CONTRIBUTED TO REPORTED INFECTION. WITHOUT ADDITIONAL INFORMATION, WE ARE UNABLE TO INVESTIGATE FURTHER. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. H10: G4 (DATE RECEIVED BY MANUFACTURER), G7 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H6 (ANNEX G ¿ COMPONENT CODE). H11: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). H11: D2 (MEDICAL DEVICE TYPE). H11: 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.
WE BECAME AWARE OF THE BELOW ADVERSE EVENT THROUGH EDC NOTIFICATION ON 10-APR-25. HOWEVER, I WAS NOT AWARE THAT THE PLEURX¿ PLEURAL CATHETER SYSTEM WAS A BD DEVICE UNTIL 15-APR-25. PLEASE NOTE, THIS EVENT IS PART OF AN IDE STUDY FOR THE BD LIVERTY¿ TIPS STENT GRAFT STUDY (NOT COMMERCIALLY AVAILABLE) AND WE ARE ONLY REPORTING ON THE POST MARKET PLEURX¿ PLEURAL CATHETER SYSTEM. ADDITIONALLY, WE ARE WORKING WITH THE SITE TO OBTAIN PRODUCT INFORMATION (LOT #, CATALOG #) AND WILL UPDATE YOU WITH THE DETAILS UPON RECEIPT. ADVERSE EVENT (VERBATIM TERM): BACTERIAL PERITONITIS START DATE: 19-MAR-2025 OUTCOME: RECOVERED / RESOLVED (RECOVERED / RESOLVED) DID AE RESULT IN ANY ADDITIONAL THERAPIES? N (NO) DATE OF ADDITIONAL THERAPY: O DEATH: N (NO) O LIFE THREATENING: N (NO) O HOSPITALIZATION: Y (YES) (B)(6) THROUGH (B)(6) 2025 . O PERMANENT IMPAIRMENT: N (NO) O MEDICAL/SURGICAL INTERVENTION: N (NO) O FETAL DISTRESS/FETAL DEATH/CONGENITAL ANOMALY/BIRTH DEFECT: N (NO) DOES THE EVENT MEET THE DEFINITION OF A MAJOR COMPLICATION?: N (NO) IF YES, WERE ALL MAJOR COMPLICATION CRITERIA MET WITHIN 30 DAYS POST-INDEX PROCEDURE? UADE: N (NO). DOES THE EVENT MEET THE DEFINITION OF A SERIOUS HEALTH THREAT? N (NO) ADDITIONAL DETAILS: DUE TO INFECTED PLEURX-CATHETER. (B)(6) 2025 AS PER FOLLOW-UP: - IT WAS ALSO REPORTED THERE WAS AN ADVERSE EVENT OF" BACTERIAL PERITONITIS". CAN YOU PLEASE CONFIRM THAT THIS WAS NOT RELATED TO THE DEVICE? THIS EVENT WAS NOT RELATED TO THE STUDY LIVERTY¿ TIPS STENT GRAFT STUDY (NOT COMMERCIALLY AVAILABLE). THE SITE DID NOT ASSESS A RELATIONSHIP TO THE PLEURX CATHETER.
WE BECAME AWARE OF THE BELOW ADVERSE EVENT THROUGH EDC NOTIFICATION ON 10-APR-25. HOWEVER, I WAS NOT AWARE THAT THE PLEURX¿ PLEURAL CATHETER SYSTEM WAS A BD DEVICE UNTIL 15-APR-25. PLEASE NOTE, THIS EVENT IS PART OF AN IDE STUDY FOR THE BD LIVERTY¿ TIPS STENT GRAFT STUDY (NOT COMMERCIALLY AVAILABLE) AND WE ARE ONLY REPORTING ON THE POST MARKET PLEURX¿ PLEURAL CATHETER SYSTEM. ADDITIONALLY, WE ARE WORKING WITH THE SITE TO OBTAIN PRODUCT INFORMATION (LOT #, CATALOG #) AND WILL UPDATE YOU WITH THE DETAILS UPON RECEIPT. AE CATEGORY: SUBJECT AE (SUBJECT AE). OUTCOME: RECOVERED / RESOLVED (RECOVERED / RESOLVED). DID AE RESULT IN ANY ADDITIONAL THERAPIES? N (NO). SAE: Y (YES). O DEATH: N (NO). O LIFE THREATENING: N (NO). O HOSPITALIZATION: Y (YES) (B)(6) 2025. O PERMANENT IMPAIRMENT: N (NO). O MEDICAL/SURGICAL INTERVENTION: N (NO). O FETAL DISTRESS/FETAL DEATH/CONGENITAL ANOMALY/BIRTH DEFECT: N (NO). DOES THE EVENT MEET THE DEFINITION OF A MAJOR COMPLICATION? N (NO). IF YES, WERE ALL MAJOR COMPLICATION CRITERIA MET WITHIN 30 DAYS POST-INDEX PROCEDURE? UADE: N (NO). DOES THE EVENT MEET THE DEFINITION OF A SERIOUS HEALTH THREAT? N (NO). ADDITIONAL DETAILS: DUE TO INFECTED PLEURX-CATHETER. 30-APRIL-2025 AS PER FOLLOW-UP: - IT WAS ALSO REPORTED THERE WAS AN ADVERSE EVENT OF" BACTERIAL PERITONITIS". CAN YOU PLEASE CONFIRM THAT THIS WAS NOT RELATED TO THE DEVICE? THIS EVENT WAS NOT RELATED TO THE STUDY LIVERTY¿ TIPS STENT GRAFT STUDY (NOT COMMERCIALLY AVAILABLE). THE SITE DID NOT ASSESS A RELATIONSHIP TO THE PLEURX CATHETER. - LOT NUMBER AND MATERIAL NUMBER ASSOCIATED WITH REPORTED ISSUE. NOT AVAILABLE. ALBAN RAJASINGH J: 30-APRIL-2025: ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER SITE- THE SITE HAS NOW PROVIDED MORE INFORMATION PERTAINING TO QUESTIONS PREVIOUSLY ASKED REGARDING THE PLEURX¿ PLEURAL CATHETER SYSTEM USED FOR SUBJECT (B)(6). (AE6) BACTERIAL PERITONITIS (NOT RELATED TO DEVICE OR PROCEDURE) IN THE ARCH STUDY. PLEASE SEE THE SITE RESPONSES IN RED BELOW: ¿ CAN YOU PLEASE CONFIRM THE CATHETER PLACED WAS PLEURX CATHETER? PLEURX DISTRIBUTED BY EWIMED. ¿ DID THE INFECTION OCCUR DUE TO THE PLEURX CATHETER? THE INFECTION (BACTERIAL PERITONITIS) WAS CONSIDERED CATHETER-ASSOCIATED BASED ON CLINICAL AND LAB EVIDENCE WITH ENTEROCOCCUS FAECIUM AND STENOTROPHOMONAS IN THE ASCITES FLUID. ¿ WAS ANY DAMAGE OBSERVED ON THE PLEURX CATHETER? NO. ¿ WHEN WAS THE INFECTION FIRST IDENTIFIED. 19-MAR-2025. THE PATIENT CAME AS EMERGENCY WITH AGGRAVATING DYSPNEA. LAB PARAMETERS WERE INCREASED FOR INFLAMMATION AND KIDNEY INJURY. ¿ DATE OF EVENT FOR THE INFECTION. FIRST DIAGNOSIS: (B)(6) 2025. ¿ REGARDING TO INFECTION, WAS THERE ANY MEDICAL INTERVENTION REQUIRED INCLUDING DIAGNOSTICS, PROCEDURES, AND TREATMENT DELAY? TREATMENT WITH PIPERACILLIN/TAZOBACATAM, LATER WITH COTRIMOXAZOL AND VANCOMYCIN. REMOVAL OF CATHETER ON (B)(6) 2025. ¿ HOW LONG HAS THE CATHETER BEEN IN PLACE, PLEASE PROVIDE PLEURX CATHETER IMPLANTATION DATE. IMPLANTATION ON (B)(6) 2025, REMOVAL ON (B)(6) 2025. ¿ WHERE WAS THE CATHETER LOCATED? ABDOMEN OR CHEST ABDOMEN. ¿ HOW WAS THE ISSUE RESOLVED? TREATMENT WITH PIPERACILLIN/TAZOBACATAM, COTRIMOXAZOL AND VANCOMYCIN LED TO DECREASED INFLAMMATION PARAMETERS. REMOVAL OF CATHETER ON (B)(6) 2025. ¿ LOT NUMBER AND MATERIAL NUMBER ASSOCIATED WITH REPORTED ISSUE. NOT AVAILABLE. ¿ COULD YOU PLEASE CONFIRM THE AWARENESS DATE. 10-APR-2025. ¿ DETAILED ISSUE DESCRIPTION? THE PATIENT CAME AS EMERGENCY WITH AGGRAVATING DYSPNEA ON (B)(6) 2025. LAB PARAMETERS WERE INCREASED FOR INFLAMMATION AND KIDNEY INJURY. ¿ COULD YOU PLEASE PROVIDE THE MATERIAL AND LOT# OF THE AFFECTED PRODUCT? NOT AVAILABLE. ¿ COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE SPECIFY IF THE SAMPLES ARE: UNUSED (BEFORE USE). USED (DURING OR AFTER USE) USED ¿ SAMPLE UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1757283 | UNKNOWN PLEURX | PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING | PNG | CAREFUSION, INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |