BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25GA COMBINED VITRECTOMY PACK WITH VALVES AND HQC

    MDR report key: 9468483 · Received December 13, 2019

    Report

    Report Number
    0001920664-2019-00255
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 28, 2019
    Report Date
    November 28, 2019
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED AND THE EVALUATION WAS COMPLETED. THE EVALUATION SHOWED THAT THE NEEDLE WAS BENT, WITH THE INNER NEEDLE BINDING UP, AND CONFIRMED THAT THE CUTTER DID NOT CUT. DUE TO THE DAMAGED CONDITION IN WHICH THE PRODUCT WAS RETURNED, A ROOT CAUSE COULD NOT BE DETERMINED. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION IS REQUIRED. THIS INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED DURING SURGERY (AFTER INSERTING THE TROCARS, BEFORE COMMENCING CORE VITREOUS REMOVAL); THE SURGEON REALIZED THE VITREOUS WAS NOT BEING CUT. THE CUTTER WAS REMOVED FROM THE EYE AND TESTED IN THE GALLIPOT AT HIGH VACUUM. THE CUTTER WAS THEN REINSERTED INTO THE EYE WITH THE SAME OUTCOME. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259513 25GA COMBINED VITRECTOMY PACK WITH VALVES AND HQC UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5525WVX W5119

    Patients

    Seq Age Sex Outcome Treatment
    1