BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED V

    MDR report key: 7852813 · Received September 6, 2018

    Report

    Report Number
    0001920664-2018-00117
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    August 10, 2018
    Report Date
    August 10, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IN THE REPORTED EVENT WAS DISPOSED THEREFORE NO EVALUATION CAN BE PERFORMED. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS HAVE BEEN SUBMITTED AGAINST LOT NUMBER W1458. CAPA 610815 WAS OPENED TO INVESTIGATE THE INCREASE IN CUTTING PROBLEMS FOR THE 23GA & 25GA CUTTER PACKS. THE CAPA WAS CLOSED ON JULY 06, 2018 BUT IT WAS STILL OPEN WHEN LOT W1458 WAS MANUFACTURED IN MARCH. PER CAPA 610815 AND QCR (B)(4) THE VITRECTOMY TUBE SET USED ON THE STELLARIS PC PACKS AND STANDALONE POUCHED VITRECTOMY CUTTERS WERE REPLACED WITH A NEW VITRECTOMY TUBE SET. THE NEW VITRECTOMY TUBE SET 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 TUBE SET ENHANCEMENT WAS IMPLEMENTED ON THE IMPACTED PC PACKS AND POUCHED ACCESSORIES, INCLUDING BL5523WV. THE FIRST LOT OF BL5523WV THAT WAS BUILT WITH THE VITRECTOMY TUBE SET ENHANCEMENT WAS LOT #W2330 IN JULY 2018. ANY BL5523WV PRODUCT WITH LOT NO. W2330 OR HIGHER WILL INCLUDE THE VITRECTOMY TUBE SET ENHANCEMENT.

    Additional Manufacturer Narrative · 1

    (REPORT#1 OF 2) WE WERE INFORMED THAT THE DEVICE INVOLVED IN THE EVENT WAS DISPOSED AT THE FACILITY AFTER THE USE. THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    A REPORT FROM A USER FACILITY IN (B)(6) STATED THAT TWO CUTTERS FAILED TO CUT THE VITREOUS ON TWO SEPARATE PATIENTS WHILE THE ASPIRATION WAS STILL WORKING. THE CUTTERS NEEDED TO BE CHANGED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692244 23GA POSTERIOR PROCEDURAL PACK WITH INTEGRATED V DEVICE, PHACOEMULSIFICATION HQC BAUSCH + LOMB BL5523WV W1458

    Patients

    Seq Age Sex Outcome Treatment
    1