BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASIC VACUUM PHACO PACK

    MDR report key: 8306748 · Received February 5, 2019

    Report

    Report Number
    0001920664-2019-00034
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 7, 2019
    Report Date
    January 8, 2019
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OPENED BL5110 PACK FROM LOT W2840 WAS RETURNED. THE ASSEMBLY WAS DIRTY WITH FLUID IN THE CASSETTE AND TUBING. EXAMINATION OF THE PACK AND THE PACK COMPONENTS FOUND NO DAMAGE OR MISSING MATERIAL. THE FLUID FROM THE COLLECTION CASSETTE WAS INSPECTED AND NO PARTICLES WERE FOUND. A SMALL PLASTIC VIAL WAS RETURNED IN A SEPARATE PLASTIC BAG. THE VIAL CONTAINED AN UNKNOWN FLUID AND A LIGHT BEIGE COLORED PARTICLE. THE PARTICLE IS APPROXIMATELY 558.03 UM (MICRONS) IN LENGTH BY 351.84 UM IN WIDTH. THE PARTICLE WAS SENT FOR LAB ANALYSIS USING AN ENERGY-DISPERSIVE SPECTROMETER (EDS) EQUIPPED SCANNING ELECTRON MICROSCOPE (SEM). EDS ANALYSIS INDICATES THAT THE BEIGE COLORED PARTICLE CONSISTS PRIMARILY OF CARBON. LESSER CONCENTRATIONS OF OXYGEN, SODIUM, CHLORINE, SILICON, AND ALUMINUM WERE ALSO DETECTED. THIS IS CONSISTENT WITH ORGANIC MATERIAL, SALINE RESIDUE, AND MINERAL DEPOSITS. THE BEIGE COLORED PARTICLE WAS ANALYZED USING A FOURIER TRANSFORM INFRARED (FTIR) SPECTROMETER. THE FTIR ANALYSIS OF THE BEIGE COLORED PARTICLE PRODUCED A SPECTRUM CONSISTENT WITH THAT OF POLYMETHACRYLATE-BUTADIENE-STYRENE (MBS). NONE OF THE COMPONENTS OR SUBASSEMBLIES IN BL5110 ARE MADE OF MBS AND MBS IS NOT USED IN THE MANUFACTURING PROCESS. A REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS FOR REASON CODE "FOREIGN MATERIAL/PARTICULATE" HAVE BEEN SUBMITTED AGAINST LOT W2480. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO FURTHER INVESTIGATION OR CORRECTIVE ACTION IS NECESSARY. PLEASE NOTE WE RECEIVED A PARTIAL BOTTLE OF AQ500P BALANCED SALT SOLUTION FROM LOT 807518. EXAMINATION OF THE BEIGE COLORED SEPTUM ON THE BALANCED SALT SOLUTION BOTTLE FOUND MATERIAL MISSING,A HOLE VISIBLE IN IT. ALSO, THERE IS A PIECE OF MATERIAL STICKING UP AT THE PIERCED LOCATION. THE SEPTUM WAS SENT FOR LAB ANALYSIS ALONG WITH THE PARTICLE AND THE SEPTUM WAS FOUND TO CONSIST OF STYRENE-BUTADIENE-RUBBER(SBR) WITH CALCIUM CARBONATE FILLER. WHILE SIMILAR IN APPEARANCE THE LAB DETERMINED THE SEPTUM AND PARTICLE TO BE DIFFERENT MATERIAL OF DIFFERENT MATERIAL ORIGINS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE USER FACILITY IN THE (B)(6) REPORTED THERE WAS A PARTICLE FOUND AT SEGMENT REMOVAL. THERE WAS NO PATIENT IMPACT OR INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101211 BASIC VACUUM PHACO PACK UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5110 W2480

    Patients

    Seq Age Sex Outcome Treatment
    1