BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACRICATH LACRIMAL DUCT CATHETER

    MDR report key: 4381528 · Received January 5, 2015

    Report

    Report Number
    1649914-2014-00066
    Event Type
    Injury
    Date Received
    January 5, 2015
    Date of Event
    December 9, 2014
    Report Date
    March 10, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    OKS
    PMA / PMN Number
    K113867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVICES WERE REJECTED AND NO SPECIFIC MANUFACTURING YIELD ISSUES WERE REPORTED SIMILAR TO THE REPORTED COMPLAINT CONDITION. THE INVESTIGATION IS ONGOING. VISUAL EXAMINATION CONFIRMED THE CATHETER BALLOON PORTION WAS BURST. THE INFLATOR WAS RETURNED WITH THE CATHETER, AND IT WAS FOUND TO BE DAMAGED. THE INFLATOR WILL PUSH AIR AS INTENDED, HOWEVER THE GAUGE DOES NOT REGISTER THE PRESSURE. THE SUPPLIER FOR THE INFLATOR HAS BEEN NOTIFIED AND FEEDBACK IS ANTICIPATED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER/SUPPLIER OF THE INFLATOR HAS BEEN NOTIFIED AND FEEDBACK WAS RECEIVED. EVALUATION OF THE DEVICE FOUND A CRACK ON THE INFLATER PUMP. IT IS SURMISED THAT THE BALLOON WAS INFLATED WITHOUT PROPER READING OF THE PRESSURE ON THE INFLATOR DEVICE, WHICH RESULTED IN THE BALLOON PORTION OF THE DEVICE RUPTURING. IMPROPER USE OF THE INFLATOR CAN RESULT IN THE FOLLOWING, PER THE MANUFACTURER: CRACKED GAUGE LENS. NEEDLE OUTSIDE THE ZERO BOX WHEN NO PRESSURE IS APPLIED. TILTED GAUGE FACE. BROKEN GAUGE HOUSING.; THE SUPPLIER DETERMINED THE INFLATOR HAD BEEN DAMAGED BY SOME EXTREME EXTERNAL FORCE. THEY REVIEWED THE EQUIPMENT AND PROCESSES RELATED TO THE MANUFACTURE OF THE INFLATOR AND FOUND NO ANOMALIES. THE ROOT CAUSE IS NOTED AS USER ERROR IN USE OF THE INFLATOR.

    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 CLINICIAN'S OFFICE REPORTED AN ISSUE WAS ENCOUNTERED WITH THE LACRICATH LACRIMAL DUCT CATHETER LDC315-T THAT WAS INCLUDED IN THE DCP315-UNIT KIT. THE INITIAL REPORT STATED THAT THE CATHETER WAS CRACKED/RUPTURED UPON USE. FOLLOW UP WITH THE FACILITY FOR ADDITIONAL INFORMATION FOUND THAT THE CATHETER RUPTURED WHILE INSERTED IN THE PATIENT'S EYE WHICH RESULTED IN SLIGHT BLEEDING. PATIENT INFORMATION (AGE, SEX, GENDER) WAS NOT PROVIDED. IT WAS REPORTED THAT THE SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER, BUT THE SAMPLE HAS NOT YET BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4271 LACRICATH LACRIMAL DUCT CATHETER LACRIMAL DUCT CATHETER OKS QUEST MEDICAL, INC. DCP315UNIT 045037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention