BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACRICATH LACRIMAL DUCT BALLOON CATHETER 3 MM

    MDR report key: 6475986 · Received April 10, 2017

    Report

    Report Number
    1649914-2017-00037
    Event Type
    Malfunction
    Date Received
    April 10, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 25, 2017
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    OKS
    UDI-DI
    10634624810195
    PMA / PMN Number
    K113867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE COMPLAINT SAMPLE WAS A DEVICE INCLUDED IN A KIT,, THERE WERE 2 POSSIBLE LOTS OF PRODUCT IT COULD HAVE BEEN. THE OTHER POSSIBLE LOT OF PRODUCT IS LOT 0523966N02 MANUFACTURE DATE 10/26/2016 EXP 10/26/2019. VISUAL EXAMINATION OF THE COMPLAINT SAMPLE FOUND THAT IT HAD BEEN USED. AFTER DECONTAMINATION, THE DEVICE WAS INFLATED TO 8ATM. THE DEVICE REMAINED INFLATED DURING PRESSURIZATION; HOWEVER, ONCE COMPLETED A LEAK WAS OBSERVED AT THE TIP. THE ROOT CAUSE IS MOST LIKELY INADEQUATE ADHESIVE TO BOND THE BALLOON TO THE CATHETER BODY. THE POSSIBLE PRODUCT LOTS WERE BOTH MANUFACTURED PRIOR TO MANUFACTURING PROCESS IMPROVEMENTS IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE FACILITY MATERIALS MANAGER REPORTED AN ISSUE ENCOUNTERED BY THE PHYSICIAN WHILE USING THE LACRIMAL DUCT CATHETER. THE REPORT STATED THAT THE DEVICE WOULD NOT REMAIN INFLATED. THE REPORT STATED THAT THE CATHETER WAS REMOVED AND A SECOND ONE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE CATHETER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260651 LACRICATH LACRIMAL DUCT BALLOON CATHETER 3 MM LACRIMAL DUCT CATHETER OKS QUEST MEDICAL, INC. LDC315T 0521446S05 10634624810195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention