BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRODISSECTION CANNULA

    MDR report key: 10700918 · Received October 19, 2020

    Report

    Report Number
    0001920664-2020-00127
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 21, 2020
    Manufacturer
    STERIMEDIX LIMITED
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CANNULA IS SUPPLIED TO THE DISTRIBUTOR AS NON STERILE FOR THEM TO PACK. IT IS POSSIBLE THE CONTAMINATION DID NOT ORIGINATE FROM THE MANUFACTURER. REVIEWING VIDEO OF THE REPORTED EVENT SHOWS AFTER THE CANNULA IS USED A SECOND TIME AND IS PUMPING LIQUID, FOR SOME TIME, THE HAIR APPEARS. THIS SUGGESTS THAT IT WAS NOT THE NEEDLE BUT THE HAIR WAS FLUSHED THROUGH IT. THE HAIR WAS EXAMINED AND WE THINK IT IS AN EYELASH EXTENSION. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS WITH THIS PRODUCT. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THE FEI NUMBER IS (B)(4). WE ARE IN THE PROCESS OF UPDATING OUR MEDWATCH FORM TO INCLUDE THIS NEW LOCATION. THE BATCH RECORD FOR THIS DEVICE HAS BEEN REVIEWED, IN ADDITION A FLOW TEST OF 100% IS PERFORMED DURING PRODUCTION TO CATCH DEFECTS WITH THE NEEDLE. NO ANOMALIES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED A "HAIR" LIKE PARTICULATE CAME OUT OF THE CANNULA AND INTO THE EYE. THE PARTICULATE WAS REMOVED WITH FORCEPS. THE CANNULA WAS USED DURING HYDRODISSECTION AND AGAIN TO CLOSE THE INCISIONS. THE CANNULA HAD BEEN DISCONNECTED TO FILL THE SYRINGE WITH BSS. NO PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166288 HYDRODISSECTION CANNULA OPHTHALMIC INFUSION/ASPIRATION CANNULA, SINGLE-USE HMX STERIMEDIX LIMITED 3907-03NSP 237058

    Patients

    Seq Age Sex Outcome Treatment
    1 BSS