BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED

    MDR report key: 7905285 · Received September 25, 2018

    Report

    Report Number
    0001920664-2018-00130
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    August 26, 2018
    Report Date
    August 26, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND. TWO VITRECTOMY CUTTERS WERE RETURNED WITHOUT PROTECTIVE CAPS AND HAD BENT NEEDLES. NEITHER CUTTER PASSED FUNCTIONALITY TESTING. THE PRODUCT EVALUATION COULD NOT VERIFY THE FAILURE MODE DUE TO THE CONDITION OF THE PRODUCT RETURN. THE PRODUCT WAS INSUFFICIENTLY PACKAGED. THERE IS A CORRECTIVE ACTION (CAPA 610815) ALREADY OPENED FOR THIS TYPE OF COMPLAINT. A REVIEW OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS FOR REASON CODE "CUTTING PROBLEM" HAVE BEEN SUBMITTED AGAINST LOT V8913. CAPA 610815 WAS CLOSED ON 06 JULY 2018 BUT WAS STILL OPEN WHEN LOT V8913 WAS MANUFACTURED IN MAR. 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, INCLUDING BL5423W. THE FIRST LOT OF BL5423W THAT WAS BUILT WITH THE VITRECTOMY TUBESET ENHANCEMENT WAS LOT #W2090 IN JUN 2018. ANY BL5423W PRODUCT WITH LOT NO. W2090 OR HIGHER WILL INCLUDE THE VITRECTOMY TUBESET ENHANCEMENT.THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION UNDERWAY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT VITRECTOMY CUTTER CAN NOT CUT THE VITREOUS BODY. THE CUTTER CONTINUED TO ASPIRATE, THE DOCTOR STOPPED USING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748853 23 GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5423W V8913

    Patients

    Seq Age Sex Outcome Treatment
    1