BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT 1000ML

    MDR report key: 21185948 · Received January 17, 2025

    Report

    Report Number
    9680904-2024-00031
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    November 27, 2024
    Report Date
    March 21, 2025
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403090707
    PMA / PMN Number
    K160450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE IS NOT AVAILABLE FOR RETURN. 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.

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, AND A DEVICE HISTORY RECORD WAS PERFORMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS 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. THE PRODUCT WAS INSPECTED DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. H10: INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H10: PMA/510K: K160437, K160450, K201155; D2: PRO CODE: DWM, PNG H10: B5, G4, G7, H2, H6 (COMPONENT CODE). H11: H6 (TYPE OF INVESTIGATION, INVESTIGATION RESULTS, AND CONCLUSIONS). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT TWO BOTTLES DID NOT HAVE PACKAGING COMPROMISING THE BOTTLES. IT WAS FURTHER REPORTED THAT THE BOTTLES WERE LOOSE. THERE WAS NO PATIENT CONTACT. VERBATIM: ITEM(S): 2 BOTTLES ARE IN HUGH BOX WITH NO PACKING LOT(S):0001585577 DATE INCIDENT OCCURRED AND THE 27TH OF NOVERMBER

    Description of Event or Problem · 0

    MATERIAL # 50-7510 BATCH # 0001585577. IT WAS REPORTED BY CUSTOMER THAT TWO BOTTLES DID NOT HAVE THE CORRECT PACKAGING TO PROTECT THE BOTTLES. IT WAS FURTHER REPORTED THAT THE BOTTLES WERE LOOSE. THERE WAS NO PATIENT CONTACT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ITEM(S): 2 BOTTLES ARE IN HUGH BOX WITH NO PACKING LOT(S):0001585577 DATE INCIDENT OCCURRE AND THE 27TH OF NOVERMBER CUSTOMER RESPONSE ON (B)(6) 2025: 1. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE "HUGH BOX WITH NO PACKING"? THE BOX WAS TOO BIG, NO PACKING MATERIAL TO PROTECT THE BOTTLES. 2. CAN YOU DESCRIBE THE EXTERNAL CONDITION OF THE BOX UPON RECEIPT, ANY SIGNS OF MISHANDLING? OUTSIDE OF BOX DID NOT EXHIBIT DAMAGE. 3. DID YOU NOTICE ANY UNUSUAL SOUNDS OR SHIFTING INSIDE THE BOX WHEN HANDLING IT? YES, THE BOTTLES INSIDE WERE MOVING WITHIN THE BOX DUE TO NO PACKAGING MATERIAL. 4. WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE BOTTLE? THE NECK SUPPORTS WE¿RE NOT INTACT. 5. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? WHEN I WENT TO USE THEM, NOTICED THE NECK SUPPORTS WERE NOT INTACT, HAD CALLED OFF AND INSIDE THE BAG. 6. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? N/A IF YES, PLEASE PROVIDE THE DETAILS. 7. WAS THERE ANY INDICATION OR SOUND OF VACUUM ESCAPING? THERE WAS NO VACUUM. 8. WHERE ARE THE BOTTLES STORED UNTIL USE? STORED IN THE BEDROOM OF PATIENT, LEFT IN THE ORIGINAL BOX. 9. WAS THE CLAMP PROPERLY CLOSED UNTIL AFTER ACTIVATING THE SUCTION? YES 10. WERE THEY ABLE TO USE ANOTHER BOTTLE SUCCESSFULLY? YES 11. SAMPLE AVAILABLE IS MENTIONED AS YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES AND YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876614 PLEURX DRAINAGE KIT 1000ML APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 0001585577 10885403090707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown