BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT 1000ML - 50-7510

    MDR report key: 11952535 · Received June 7, 2021

    Report

    Report Number
    9680904-2021-00061
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 21, 2021
    Product Code
    DWM
    UDI-DI
    10885403090707
    PMA / PMN Number
    K160450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PR 2912104 FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE SAMPLE OF LOT 0001387892 WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED CRACKED ON SURFACE OF ACCESS TIP AND LEAKAGE OCCURRED BECAUSE OF THE CRACKED ON THE ACCESS TIP, THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR REPORTED LOTS 0001387892 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. WHILE WE DID NOT IDENTIFY A DIRECT ISSUE, A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE THESE DEFECTS. THROUGH OUR INVESTIGATION, WE IDENTIFIED THE DEFECT CAN BE PRODUCED DUE TO PINS IN THE ACCESS DILATOR MOLD BECOMING BENT DURING PRODUCTION. IMPROVEMENTS ARE IN THE PROCESS OF BEING IMPLEMENTED TO ENSURE THAT REPAIRS AND MAINTENANCE ORDERS ARE IN ALIGNMENT WITH ESTABLISHED DOCUMENTATION PROCESSES, ALLOWING FOR ROBUST VERIFICATION OF THE CONDITION OF THE MOLD. ACTIONS HAVE BEEN TAKEN TO ASSESS AND REPLACE BENT PINS WITHIN THE MOLD FOR THE ACCESS DILATOR. IMPROVED INSPECTIONS AND ADDITIONAL PERSONNEL TRAINING HAVE BEEN IMPLEMENTED. IN ADDITION, ENHANCED PREVENTATIVE MAINTENANCE PROCEDURES ARE CURRENTLY BEING ADDED TO THE PROCESS.

    Description of Event or Problem · 0

    MATERIAL NO: (B)(4). BATCH NO: 0001387892   IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH LEAKING AT THE CONNECTION POINT DEFECTIVE ISSUE; NO PT HARM ¿ EVENT DESCRIPTION STATES: LEAKING AT THE CONNECTION POIN  QUESTIONS/INQUIRIES: -CONFIRM PATIENT HARM AND NOTATE IN EVENT DESC PER ATTACHED STATEMENT ABOVE PLEASE REACH OUT AND REQUEST TO VERIFY THE FOLLOWING: - WHERE DID LEAKAGE OCCURRED? - AT THE ACCESS TIP TO CATHETER - IS THIS AT THE ACCESS TIP AND THE CATHETERS VALVE? IF IT AT THE ACCESS TIP DID THE ACCESS TIP FULLY CLICKED IN TO THE VALVE? - YES AT THE ACCESS TIP TO CATHETER - DID THE LEAKAGE OCCURRED TO THE DRAINAGE LINE TO THE BOTTLE? - WAS THERE DAMAGE NOTED ON THE ACCESS TIP OR PATIENT'S VALVE. - YES BENT - WHERE IS THE CATHETER LOCATED? 1:00PMCST (B)(6)2021 - SPOKE TO CUSTOMER - HAS SAMPLE AVAIL REFERRED TO IN EMAIL ATTACHED - AFTER PLUNGER ENGAGED AND ROLLER RELEASED THE LEAKING TAKES PLACE AT THE ACCESS TIP/CATHETER CONNECTION - NOTICED AT TIMES THAT THE ACCESS TIP APPEARS TO BE BENT - CUSTOMER EXPLAINED THAT HE KEPT SAMPLES OF THE AFFECTED BOTTLES AND IS READY TO SEND THEM - ASKED THAT WE SEND LABELS - NO PT HARM.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO: 50-7510. BATCH NO: 0001387892. ¿ IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH LEAKING AT THE CONNECTION POINT DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: LEAKING AT THE CONNECTION POIN ¿QUESTIONS/INQUIRIES: CONFIRM PATIENT HARM AND NOTATE IN EVENT DESC PER ATTACHED STATEMENT ABOVE PLEASE REACH OUT AND REQUEST TO VERIFY THE FOLLOWING: WHERE DID LEAKAGE OCCURRED? AT THE ACCESS TIP TO CATHETER. IS THIS AT THE ACCESS TIP AND THE CATHETERS VALVE? IF IT AT THE ACCESS TIP DID THE ACCESS TIP FULLY CLICKED IN TO THE VALVE? YES AT THE ACCESS TIP TO CATHETER. DID THE LEAKAGE OCCURRED TO THE DRAINAGE LINE TO THE BOTTLE? WAS THERE DAMAGE NOTED ON THE ACCESS TIP OR PATIENT'S VALVE. YES BENT. WHERE IS THE CATHETER LOCATED? AT 1:00PMCST 27MAY21 - SPOKE TO CUSTOMER - HAS SAMPLE AVAIL REFERRED TO IN EMAIL ATTACHED - AFTER PLUNGER ENGAGED AND ROLLER RELEASED THE LEAKING TAKES PLACE AT THE ACCESS TIP/CATHETER CONNECTION - NOTICED AT TIMES THAT THE ACCESS TIP APPEARS TO BE BENT -CUSTOMER EXPLAINED THAT HE KEPT SAMPLES OF THE AFFECTED BOTTLES AND IS READY TO SEND THEM - ASKED THAT WE SEND LABELS - NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847975 PLEURX DRAINAGE KIT 1000ML - 50-7510 APPARATUS, SUCTION, PATIENT CARE DWM 50-7510 0001387892 10885403090707

    Patients

    Seq Age Sex Outcome Treatment
    1 Other