BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23G POSTERIOR PROCEDURAL PACK WITH WF

    MDR report key: 8312335 · Received February 6, 2019

    Report

    Report Number
    0001920664-2019-00014
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 15, 2019
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    20757770058086
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4 DATE. EVALUATION COMPLETED. ONE OPENED BL5223W PACK FROM LOT W0378 WAS RETURNED. THE EXPIRATION DATE ON THE LABEL WAS 2019-MAR-24. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS BENT. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION AND WHAT LOOKS LIKE ORGANIC MATERIAL IN THE TUBING. THIS ASSEMBLY LOOKS USED. 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 CUTTER WAS CLOGGED, PREVENTING CUTTING AND ASPIRATION. DUE TO EVIDENCE OF USE, THE CAUSE OF THE BLOCKAGE CANNOT 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. CAPA 610815 WAS CLOSED ON (B)(6)2018 BUT WAS STILL OPEN WHEN LOT W0378 WAS MANUFACTURED. PER CAPA 610815 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 BL5223W. THE FIRST LOT OF BL5223W THAT WAS BUILT WITH THE VITRECTOMY TUBESET ENHANCEMENT WAS LOT #W2087 IN (B)(6)2018. ANY BL5223W PRODUCT WITH LOT NO. W2087 OR HIGHER WILL INCLUDE THE VITRECTOMY TUBESET ENHANCEMENT. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS HAVE BEEN SUBMITTED AGAINST LOT# W0378. INVESTIGATION COMPLETE. REPORT 1 OF 2 SEE 1920664-2019-00015.

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. FURTHER INVESTIGATION UNDERWAY. REPORT 1 OF 2. SEE 9120664-2019-00015.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER COULD NOT CUT DURING SURGERY. ASPIRATION CONTINUED WHEN THE CUTTER STOPPED. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104987 23G POSTERIOR PROCEDURAL PACK WITH WF UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5223W W0378 20757770058086

    Patients

    Seq Age Sex Outcome Treatment
    1