BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT 500ML 10/CS

    MDR report key: 21011566 · Received December 24, 2024

    Report

    Report Number
    1625685-2024-00150
    Event Type
    Malfunction
    Date Received
    December 24, 2024
    Date of Event
    November 15, 2024
    Report Date
    March 18, 2025
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403090714
    PMA / PMN Number
    K160437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS CURRENTLY UNDERWAY. THE DEVICE WAS NOT RETURNED. THE INVESTIGATION IS CURRENTLY UNDERWAY. H10: PMA-510K: K160437, K160450, K201155, K971753, D2, PRO CODE DWM, PNG. 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. 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, K971753; D2 PRO CODE DWM, PNG. H10: B5, E1, G4, G7, H2, H6 (COMPONENT CODE). H11: H6 (TYPE OF INVESTIGATION, INVESTIGATION RESULTS, AND INVESTIGATION 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

    MATERIAL NO: 50-7500B BATCH NO: 0001567492. IT WAS REPORTED THAT THE ACCESS TIP WAS CRACKED. THERE WAS NO PATIENT HARM. VERBATIM: IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: ¿DEFECTIVE CAP¿. RCC RECEIVED A COMPLAINT VIA EMAIL. COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? 2 KITS HAD ACCESS TIP WAS CRACKED /1 KIT HAD A DRIED ALCOHOL PAD ACCORDING TO CUSTOMER ALL FROM SAME LOT. WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE CAP? TO THE ACCESS TIP LEAKAGE DID OCCUR ON ONE OF THE TWO CRACKED ACCESS TIPS, THE OTHER WAS CAUGHT BEFORE. WHAT WAS THE IMPACT TO THE PATIENT? NO . DID THE ISSUE HAPPEN DURING PATIENT USE? YES DURING DRAINING IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NO IF YES, PLEASE PROVIDE MAILING ADDRESS AND EMAIL ADDRESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ACCESS TIP WAS CRACKED. THERE WAS NO PATIENT HARM. VERBATIM: IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH DEFECTIVE ISSUE; NO PT HARM EVENT DESCRIPTION STATES: ¿DEFECTIVE CAP¿ RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. - COULD YOU PLEASE PROVIDE A FURTHER DESCRIPTION OF THE ISSUE? 2 KITS HAD ACCESS TIP WAS CRACKED /1 KIT HAD A DRIED ALCOHOL PAD ACCORDING TO CUSTOMER ALL FROM SAME LOT - WAS THERE ANY DAMAGE OR VISIBLE DEFECT WITH THE CAP? TO THE ACCESS TIP LEAKAGE DID OCCUR ON ONE OF THE TWO CRACKED ACCESS TIPS, THE OTHER WAS CAUGHT BEFORE. - WHAT WAS THE IMPACT TO THE PATIENT? NO - DID THE ISSUE HAPPEN DURING PATIENT USE? YES DURING DRAINING IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? - IS THERE A PHOTO OR SAMPLE AVAILABLE SHOWING THE REPORTED ISSUE? NO IF YES, PLEASE PROVIDE MAILING ADDRESS AND EMAIL ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2364624 PLEURX DRAINAGE KIT 500ML 10/CS APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 0001567492 10885403090714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown