BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30G RYCROFT CANNULA

    MDR report key: 12093077 · Received June 30, 2021

    Report

    Report Number
    0001920664-2021-00080
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Report Date
    June 1, 2021
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. HOWEVER, A SMALL AMOUNT OF PARTICULATE WAS UNCOVERED DURING GOODS INSPECTION AND THE SUPPLIER WAS CONTACTED AS PART OF OUR COMMITMENT TO CONTINUOUS IMPROVEMENT. THE WHITE CONTAMINATION OBSERVED WAS DEEMED TO HAVE COME FROM THE SUPPLIER. FURTHER INSPECTION FOUND THAT SOME OF THE PRODUCTS EXHIBITED SMALL AMOUNTS OF WHITE CONTAMINATION SIMILAR TO THOSE REPORTED IN THE COMPLAINT, BUT WITHIN THE PARTICULATE SPECIFICATIONS. THE SUPPLIER¿S PRODUCT WAS SENT FOR PARTICULATE AND ELEMENTAL ANALYSIS TESTING OF THE CONTAMINATION. THE CONTAMINATION WAS DETERMINED TO BE TRACES OF MINERALS CONSISTENT WITH HARD WATER USED IN THE SUPPLIER''S WASH PROCESS. WE HAVE SINCE INCREASED OUR INTERNAL INSPECTION OF THESE PRODUCTS AND IMPLEMENTED UPDATED STANDARDS TO ENSURE THAT THIS DOES NOT REOCCUR. THE SUPPLIER HAS ALSO IMPLEMENTED 100% INSPECTION OF ALL PRODUCTS. THE INVESTIGATION IS COMPLETE. D3 MANUFACTURE NAME AND ADDRESS: BAUSCH + LOMB, ROCHESTER, NY-NEW YORK, UNITED STATES (USA), 14609 REPORTED IN ERROR. CORRECTED MANUFACTURE NAME AND ADDRESS: STERIMEDIX LIMITED, REDDITCH, UNITED KINGDOM (GBR), B98 9ND.

    Additional Manufacturer Narrative · 0

    THE TYPE OF SURGERY BEING PERFORMED WAS A CATARACT SURGERY WHERE THE PARACENTESIS WAS PART OF THE SURGERY. THE WHITE MATERIAL WAS FLUSHED OUT OF THE EYE WITHOUT INCISION AND THE MATERIAL WAS SUCCESSFULLY REMOVED. THE PATIENT WAS MONITORED AND THE PATIENT'S CURRENT STATUS IS FINE. THE PROCEDURE TOOK A FEW MINUTES LONGER THAN NORMAL AND NO ADDITIONAL ANESTHESIA WAS REQUIRED FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A FACILITY IN (B)(6) REPORTED THAT THE OPHTHALMOLOGY SURGEON NOTICED, UNDER A MICROSCOPE, THAT THERE WAS WHITE MATERIAL ATTACHED TO THE PACKS ON A NUMBER OF OCCASIONS. THE REPORTER ALSO NOTICED DEBRIS NEAR THE TIP AND BEND OF THE CANNULA. DURING ONE SURGERY, THE SURGEON NOTICED WHITE MATERIAL IN THE PARACENTESIS OF THE PATIENT'S EYE. THE SURGEON WAS ABLE TO REMOVE THE MATERIAL FROM THE PATIENT'S EYE BUT IT WAS DIFFICULT TO FLUSH OUT. NO MEDICAL INTERVENTION WAS NECESSARY AND NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990229 30G RYCROFT CANNULA CANNULA, OPHTHALMIC HMX 2273-03T 222

    Patients

    Seq Age Sex Outcome Treatment
    1