BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 GAUGE COMBINED PROCEDURE PACK

    MDR report key: 7516163 · Received May 15, 2018

    Report

    Report Number
    0001920664-2018-00058
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Report Date
    April 24, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    20757770058185
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER CAPA (B)(4) AND QCR (B)(4) THE VITRECTOMY TUBESET USED ON STELLARIS PC PACK BL5525W WAS REPLACED WITH A NEW VITRECTOMY TUBESET. THE NEW VITRECTOMY TUBESET PROVIDES A GREATER OPERATING RANGE BETWEEN THE PRESSURE REQUIRED TO CLOSE THE VITRECTOMY CUTTER INNER NEEDLE AND THE PRESSURE REQUIRED TO OPEN THE VITRECTOMY CUTTER INNER NEEDLE. THE VITRECTOMY TUBESET ENHANCEMENT WAS IMPLEMENTED IN (B)(6) 2018. THE PRODUCT REPORTED IN THIS EVENT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THE ENHANCEMENT.

    Additional Manufacturer Narrative · 1

    ONE OPENED BL5525W PACK FROM LOT W0399 WAS RECEIVED. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS BENT AND CURVED. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION VISIBLE IN THE TUBING. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. THE CONNECTORS WERE INSPECTED AND NO DEFECTS WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE CUTTER DID NOT CUT. THE INNER NEEDLE WAS BINDING UP AND BLOCKING THE PORT WINDOW, PREVENTING CUTTING AND ASPIRATION. A BENT NEEDLE COULD CONTRIBUTE TO POOR CUTTING PERFORMANCE. THE CAUSE OF THE BENT NEEDLE CANNOT BE DETERMINED. A CORRECTIVE AND PREVENTATIVE ACTION HAS BEEN OPENED FOR THIS TYPE OF COMPLAINT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED YET NOT RECEIVED. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    Description of Event or Problem · 1

    THE VITRECTOMY CUTTER DOES NOT CUT YET CONTINUES TO ASPIRATE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358071 23 GAUGE COMBINED PROCEDURE PACK UNIT. PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5525W W0399 20757770058185

    Patients

    Seq Age Sex Outcome Treatment
    1 Other