BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLEURX DRAINAGE KIT 1000ML

    MDR report key: 16895074 · Received May 9, 2023

    Report

    Report Number
    9680904-2023-00022
    Event Type
    Death
    Date Received
    May 9, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 23, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403090707
    PMA / PMN Number
    K160437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 7831105 INITIAL EMDR SUBMISSION. DEVICE PROBLEM CODE: A24. PATIENT PROBLEM CODE: F26. (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001449373 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. DURING OUR INVESTIGATION IT WAS IDENTIFIED THAT PERSONNEL WERE NOT FOLLOWING PROPER PROCEDURE WHEN APPLYING THE SILICONE USED TO ASSEMBLE THE FLEXIBLE CAP TO THE BOTTLE, WHICH CAN IMPACT THE VACUUM OF THE BOTTLE. A SYSTEM WILL BE IMPLEMENTED TO AVOID ANY FUTURE ISSUES RELATED TO INCONSISTENCIES IN DISPENSING THE SILICON AND ADDITIONAL TRAINING WILL BE PERFORMED WITH MANUFACTURING PERSONNEL. PER THE INFORMATION RECEIVED FROM THE CUSTOMER THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURE NARRATION.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW-UP EMDR FOR CORRECTION: PER THE INFORMATION RECEIVED FROM THE CUSTOMER- "PATIENT HAS RECENTLY PASSED ON (B)(6)2023 FROM RESPIRATORY FAILURE AND CONFIRMED THERE WAS NO CONTRIBUTION TO THE DEATH FROM THE PRODUCT." AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE BD DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. REPORTED EVENT IS NOT MDR REPORTABLE. SUPPLEMENTAL MDR SUBMITTED TO REFLECT THE NON-REPORTABLE DECISION.

    Description of Event or Problem · 0

    IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: NO VACUUM SUCTION. (B)(6) 2023 CALLED CUSTOMER TO FOLLOW UP ON REPORTED ISSUE. SPOKE WITH BROTHER OF PATIENT AND WAS ABLE TO GATHER THE FOLLOWING DETAILS. HE STATED THAT PATIENT HAS RECENTLY PASSED ON (B)(6) 2023 FROM RESPIRATORY FAILURE AND CONFIRMED THERE WAS NO CONTRIBUTION TO THE DEATH FROM THE PRODUCT. BROTHER CONFIRMED ISSUE WAS BOTTLE HAD NO SUCTION. THERE WAS NO PATIENT IMPACT AND THEY DO NOT HAVE THE PRODUCT TO RETURN.

    Description of Event or Problem · 0

    MATERIAL NO: 50-7510, BATCH NO: 0001449373. IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: NO VACUUM SUCTION. 04-MAY-2023 CALLED CUSTOMER TO FOLLOW UP ON REPORTED ISSUE. SPOKE WITH BROTHER OF PATIENT AND WAS ABLE TO GATHER THE FOLLOWING DETAILS. HE STATED THAT PATIENT HAS RECENTLY PASSED ON (B)(6) 2023 FROM RESPIRATORY FAILURE AND CONFIRMED THERE WAS NO CONTRIBUTION TO THE DEATH FROM THE PRODUCT. BROTHER CONFIRMED ISSUE WAS BOTTLE HAD NO SUCTION. THERE WAS NO PATIENT IMPACT AND THEY DO NOT HAVE THE PRODUCT TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841081 PLEURX DRAINAGE KIT 1000ML APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 50-7510 0001449373 10885403090707

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death