BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT 1000ML

    MDR report key: 10948945 · Received December 4, 2020

    Report

    Report Number
    9680904-2020-00040
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 9, 2020
    Report Date
    December 16, 2020
    Product Code
    DWM
    UDI-DI
    10885403090707
    PMA / PMN Number
    K160450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP EMDR FOR DEVICE EVALUATION. NO PHOTO OR PHYSICAL SAMPLE THAT DISPLAYS THE REPORTED CONDITION WAS AVAILABLE FOR EVALUATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE LOT 0001361167 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. ASSEMBLY OF THE DRAINAGE LINE ONTO THE SPIKE IS PERFORMED MANUALLY. ONCE THE ADHESIVE IS APPLIED ONTO THE DRAINAGE LINE, IT IS THEN CONNECTED ONTO THE SPIKE AND PERSONNEL MUST HOLD THE JUNCTION BEFORE THE PRODUCT MOVES ONTO THE NEXT STAGE OF ASSEMBLY. DURING OUR INVESTIGATION IT WAS IDENTIFIED THAT PERSONNEL WERE NOT FOLLOWING PROPER PROCEDURE AFTER APPLYING THE ADHESIVE ONTO THE DRAINAGE LINE AND WERE MOVING THE PRODUCT WITHOUT HOLDING THE CONNECTION FOR THE APPROPRIATE AMOUNT OF TIME. ADDITIONALLY, WE IDENTIFIED THAT PREVENTATIVE MAINTENANCE WAS NOT PROPERLY PERFORMED ON ONE OF THE MACHINES WHICH ADHERES THE DRAINAGE LINE TO THE SPIKE. BASED ON THE QUALITY TEAM'S INVESTIGATION, IT WAS DETERMINED THAT THE DISCONNECTED DRAINAGE LINE WAS LIKELY DUE TO BOTH PERSONNEL NOT FOLLOWING PROCEDURE AND MANUFACTURING EQUIPMENT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT AND ADDITIONAL TRAINING WAS PROVIDED. UPDATES WILL BE IMPLEMENTED TO ENSURE THE PROPER MAINTENANCE IS PERFORMED ON THE MANUFACTURING EQUIPMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED FOR FUTURE OCCURRENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: 2 PLEURX KITS HAD DRAINAGE LINES THAT DISCONNECTED FROM BOTTLE. 18-NOV-2020 : 11:46 AM CST - SPOKE WITH CUSTOMER'S ROOMMATE - NO HARM; PRIOR TO OPENING THE BAG THE DISCONNECT WAS NOTICED - THE HOME HEALTHCARE NURSE TRIED TO STILL USE THEM INITIALLY. ROOMMATE STATED 1 HAD NO SUCTION AT ALL, THE SECOND HAD A WEAK SUCTION, NURSE ABLE TO PULL A LITTLE BIT BEFORE THE SUCTION RAN OUT. THE NURSE DISCARDED BOTH BOTTLES AND WAS ABLE TO COMPLETE A FULL DRAINAGE WITH SUBSEQUENT BOTTLE.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: 2 PLEURX KITS HAD DRAINAGE LINES THAT DISCONNECTED FROM BOTTLE. ON (B)(6) 2020: 11:46 AM. CST SPOKE WITH CUSTOMER'S ROOMMATE. NO HARM; PRIOR TO OPENING THE BAG THE DISCONNECT WAS NOTICED .THE HOME HEALTHCARE NURSE TRIED TO STILL USE THEM INITIALLY. ROOMMATE STATED 1 HAD NO SUCTION AT ALL, THE SECOND HAD A WEAK SUCTION, NURSE ABLE TO PULL A LITTLE BIT BEFORE THE SUCTION RAN OUT. THE NURSE DISCARDED BOTH BOTTLES AND WAS ABLE TO COMPLETE A FULL DRAINAGE WITH SUBSEQUENT BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1414335 PLEURX DRAINAGE KIT 1000ML APPARATUS, SUCTION, PATIENT CARE DWM 50-7510 0001361167 10885403090707

    Patients

    Seq Age Sex Outcome Treatment
    1