BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEURX CATHETER- UNKNOWN

    MDR report key: 16326019 · Received February 8, 2023

    Report

    Report Number
    1625685-2023-00019
    Event Type
    Injury
    Date Received
    February 8, 2023
    Date of Event
    January 20, 2023
    Report Date
    February 16, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 7001921 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A0504. PATIENT PROBLEM CODE: F24. NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. SHOULD YOU EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT, EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHOTO SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTO, IT WAS OBSERVED THAT AN OSTOMY BAG IS PLACED AROUND THE SITE WHERE THE CATHETER IS PLACED. WE ARE UNABLE TO LOCATE THE SOURCE OF THE LEAKAGE. THE BAG OBSCURES THE VIEW OF THE OF THE CATHETER SITE. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURE NARRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THEY WOULD LIKE TO KNOW HOW TO MANAGE LEAKING AROUND THE PLEURX SITE. VERBATIM: REF#(B)(4). I AM THE QA RN COORDINATOR AT SUTTER COAST HOME CARE. I AM CONTACTING YOU REGARDING HOW TO MANAGE LEAKING AROUND THE PLEURX SITE. WE HAVE A PATIENT THAT WAS SENT HOME FROM THE HOSPITAL WITH AN OSTOMY BAG COVERING THEIR PLEURX SITE. WE SENT THE PATIENT BACK TO THE HOSPITAL TO ADDRESS THIS. THE HOSPITAL HAD PLACED ITTO MANAGE FLUID DRAINING AROUND THE PLEURX SITE. NURSE DID NOTE THAT THE SUTURES WERE OUT. PHYSICIANS HAVE BEEN NOTIFIED. VISITING NURSE ALSO REPORTS THEY ARE LEAVING THE EMERGENCY CLIP ON FULL TIME. WE ARE AWAITING RESPONSE FROM SURGEON IF THEY WILL SCHEDULE TO HAVE IT RE-SUTURED. IN THE MEANTIME ¿ IT IS REPORTED THAT THE SKIN AROUND THE SITE IS EXCORIATED AND WANT TO CONFIRM OK TO CLEAN EXCORIATED SKIN WITH NORMAL SALINE AND APPLY CALMOSEPTINE OVER SKIN OR ANOTHER SKIN PROTECTANT. IS THERE A CONTACT NUMBER FOR NURSES TO BE ABLE TO CALL IN THE FIELD? WE ARE IN A RURAL AREA AND WE HAVE A VERY LOW VOLUME OF PATIENTS THAT USE PLEURX DEVICES. RESPONSE EMAILED PLEASE SEE ATTACHED PLEURX IFUS. THE PLEURX DEVICE IS SILICONE AND WE HAVE NO INFORMATION ON HOW CALMOSEPTINE OINTMENT MIGHT AFFECT THE CATHETER SO WE CANNOT RECOMMEND ITS USE. WE DO RECOMMEND THAT THE FENESTRATIONS MUST BE ENTIRELY WITHIN THE PLEURAL OR PERITONEAL SPACE TO AVOID LEAKAGE INTO THE TUNNEL TRACT. IF FLUID IS LEAKING AROUND THE CATHETER SITE, APPLY A CLEAN DRESSING AND IMMEDIATELY CONTACT THE PHYSICIAN. PAIN, REDNESS, WARMTH TO TOUCH, SWELLING, FEVER, OR FLUID AROUND THE SITE MAY INDICATE THE CATHETER IS INFECTED. SOME DISCOMFORT AND REDNESS AFTER INSERTION IS EXPECTED BUT SHOULD NOT PERSIST OR WORSEN. IF FLUID IS LEAKING AROUND THE VALVE, THEN INSPECT THE CATHETER FOR CUTS OR DAMAGE. IF NECESSARY, USE THE BLUE EMERGENCY SLIDE CLAMP. IMMEDIATELY CONTACT THE PHYSICIAN. OUR DEPARTMENT, MEDICAL INFORMATION, IS CLINICAL SUPPORT FOR THE PLEURX DEVICE. YOU AND/OR STAFF MAY CALL US FOR RECOMMENDATIONS AT 800-555-7422. WE HAVE ALSO SENT THIS INFORMATION OVER TO OUR FIELD ASSURANCE DEPARTMENT. THEY MAY CONTACT YOU FOR MORE INFORMATION. ATTACHED PLEURX DRAINAGE PROCEDURE AND PLEURX PLEURAL CATHETER IFUS. COPY TO [email protected].

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THEY WOULD LIKE TO KNOW HOW TO MANAGE LEAKING AROUND THE PLEURX SITE. VERBATIM: REF#(B)(4). I AM THE QA RN COORDINATOR AT SUTTER COAST HOME CARE. I AM CONTACTING YOU REGARDING HOW TO MANAGE LEAKING AROUND THE PLEURX SITE. WE HAVE A PATIENT THAT WAS SENT HOME FROM THE HOSPITAL WITH AN OSTOMY BAG COVERING THEIR PLEURX SITE. WE SENT THE PATIENT BACK TO THE HOSPITAL TO ADDRESS THIS. THE HOSPITAL HAD PLACED ITTO MANAGE FLUID DRAINING AROUND THE PLEURX SITE. NURSE DID NOTE THAT THE SUTURES WERE OUT. PHYSICIANS HAVE BEEN NOTIFIED. VISITING NURSE ALSO REPORTS THEY ARE LEAVING THE EMERGENCY CLIP ON FULL TIME. WE ARE AWAITING RESPONSE FROM SURGEON IF THEY WILL SCHEDULE TO HAVE IT RE-SUTURED. IN THE MEANTIME ¿ IT IS REPORTED THAT THE SKIN AROUND THE SITE IS EXCORIATED AND WANT TO CONFIRM OK TO CLEAN EXCORIATED SKIN WITH NORMAL SALINE AND APPLY CALMOSEPTINE OVER SKIN OR ANOTHER SKIN PROTECTANT. IS THERE A CONTACT NUMBER FOR NURSES TO BE ABLE TO CALL IN THE FIELD? WE ARE IN A RURAL AREA AND WE HAVE A VERY LOW VOLUME OF PATIENTS THAT USE PLEURX DEVICES. RESPONSE EMAILED PLEASE SEE ATTACHED PLEURX IFUS. THE PLEURX DEVICE IS SILICONE AND WE HAVE NO INFORMATION ON HOW CALMOSEPTINE OINTMENT MIGHT AFFECT THE CATHETER SO WE CANNOT RECOMMEND ITS USE. WE DO RECOMMEND THAT THE FENESTRATIONS MUST BE ENTIRELY WITHIN THE PLEURAL OR PERITONEAL SPACE TO AVOID LEAKAGE INTO THE TUNNEL TRACT. IF FLUID IS LEAKING AROUND THE CATHETER SITE, APPLY A CLEAN DRESSING AND IMMEDIATELY CONTACT THE PHYSICIAN. PAIN, REDNESS, WARMTH TO TOUCH, SWELLING, FEVER, OR FLUID AROUND THE SITE MAY INDICATE THE CATHETER IS INFECTED. SOME DISCOMFORT AND REDNESS AFTER INSERTION IS EXPECTED BUT SHOULD NOT PERSIST OR WORSEN. IF FLUID IS LEAKING AROUND THE VALVE, THEN INSPECT THE CATHETER FOR CUTS OR DAMAGE. IF NECESSARY, USE THE BLUE EMERGENCY SLIDE CLAMP. IMMEDIATELY CONTACT THE PHYSICIAN. OUR DEPARTMENT, MEDICAL INFORMATION, IS CLINICAL SUPPORT FOR THE PLEURX DEVICE. YOU AND/OR STAFF MAY CALL US FOR RECOMMENDATIONS AT 800-555-7422. WE HAVE ALSO SENT THIS INFORMATION OVER TO OUR FIELD ASSURANCE DEPARTMENT. THEY MAY CONTACT YOU FOR MORE INFORMATION. ATTACHED PLEURX DRAINAGE PROCEDURE AND PLEURX PLEURAL CATHETER IFUS. COPY TO [email protected]. ADDITIONAL INFORMATION RECEIVED 08-FEB-2023 WHAT IS THE DATE OF EVENT? ¿ 1/18/2023 WHAT IS THE MATERIAL NUMBER? ¿ NOT DOCUMENTED UPON INITIAL INSERTION WHAT IS THE LOT NUMBER? - NOT DOCUMENTED UPON INITIAL INSERTION WHERE DID THE LEAKAGE OCCURRED? IS THIS AT THE ACCESS TIP AND THE CATHETERS VALVE? ¿ UNABLE TO DETERMINE DUE TO DEVICE BEING COVERED IN AN COLOSTOMY BAG WAS THERE ANY DAMAGE NOTICED ON CATHETER VALVE? ¿ UNABLE TO DETERMINE DUE TO VALVE SOAKING IN DRAINAGE INSIDE COLOSTOMY BAG. WAS THE VALVE CRACKED OR BROKEN? UNABLE TO DETERMINE, EMERGENCY CLAMP WAS IN PLACE. WHERE IS THE CATHETER LOCATED? ABDOMEN OR CHEST - ABDOMEN HOW LONG HAS THE CATHETER BEEN IN PLACE ¿ INSERTED (B)(6) 2023 WAS THERE ANY USE ON PATIENT? IF SO WAS THERE ANY IMPACT OR HARM DUE TO THE REPORTED ISSUE? ¿ PT DIED ON (B)(6) 2023, UNABLE TO TELL IF RELATED TO DEVICE DUE TO MULTIPLE MEDICAL COMORBIDITIES. WAS THERE ANY NEED FOR MEDICAL TREATMENT OR INTERVENTION? ¿ YES. HOSPITALIZED (B)(6) 2022 ¿ (B)(6) 2023 ¿ (B)(6) 2023 (PT DIED INPATIENT) DO YOU HAVE ANY PHOTOS TO SHOW THE REPORTED ISSUE? ¿ YES, PLEASE SEE ATTACHED DO YOU HAVE THE PRODUCT TO SEND BACK FOR EVALUATION? IF SO PLEASE PROVIDE THE SHIPPER¿S CONTACT AND ADDRESS INFORMATION FOR A SAMPLE RETURN LABEL TO BE CREATED. ¿ N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2281642 PLEURX CATHETER- UNKNOWN APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| D