BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED V

    MDR report key: 7784714 · Received August 15, 2018

    Report

    Report Number
    0001920664-2018-00106
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Report Date
    July 26, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    00757770058631
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE VITRECTOMY CUTTER WAS RECEIVED LOOSE IN A PLASTIC BAG. THE TIP PROTECTOR WAS LOOSE IN THE BAG. THE TIP WAS BENT. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS FLUID IN THE LINES. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. THE CONNECTORS WERE INSPECTED AND NO DAMAGE WAS 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, PREVENTING CUTTING AND ASPIRATION. IT SHOULD BE NOTED THAT A BENT NEEDLE COULD CONTRIBUTE TO POOR CUTTING PERFORMANCE. HOWEVER, DUE TO THE RETURNED CONDITION, LOOSE IN A PLASTIC BAG WITH EVIDENCE OF USE, THE CAUSE OF THE BENT NEEDLE CANNOT BE DETERMINED. REFER TO CAPA 610815. CAPA 610815 WAS CLOSED ON 06 JULY 2018 BUT WAS STILL OPEN WHEN LOT W0224 WAS MANUFACTURED IN SEPTEMBER 2017. PER CAPA 610815 AND QCR 332663 THE VITRECTOMY TUBESET USED ON THE STELLARIS PC PACKS AND STANDALONE POUCHED VITRECTOMY CUTTERS 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 ON THE IMPACTED PC PACKS AND POUCHED ACCESSORIES. THE FIRST LOT OF BL5525WV THAT WAS BUILT WITH THE VITRECTOMY TUBESET ENHANCEMENT WAS LOT #W1840 IN MAY 2018. ANY BL5525WV PRODUCT WITH LOT NO. W1840 OR HIGHER WILL INCLUDE THE VITRECTOMY TUBESET ENHANCEMENT.

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED FOR EVALUATION HOWEVER IT HAS NOT BEEN RECEIVED. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    Description of Event or Problem · 1

    DURING A CATARACT SURGERY THE VITRECTOMY CUTTER DID NOT CUT. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627445 25 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED V UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5525WV W0024 00757770058631

    Patients

    Seq Age Sex Outcome Treatment
    1