BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REGEN¿ THT® NC

    MDR report key: 7098778 · Received December 7, 2017

    Report

    Report Number
    1917413-2017-00562
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    February 13, 2017
    Report Date
    November 20, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: MEDICAL DEVICE LOT #: 6182782, MEDICAL DEVICE EXPIRATION DATE: 8/31/2018, DEVICE MANUFACTURE DATE: 6/30/2016. INITIAL REPORTER PHONE #: (B)(6). RESULTS: EIGHT (8) CUSTOMER PHOTOS WERE RECEIVED AND EVALUATED. PHOTO PROVIDED SHOWS 2 TUBES WITH FM ON THE STOPPER. FOUR (4) TUBES WERE CONFIRMED FROM PHOTOS TO HAVE TORN OR DAMAGED LABELS FROM PHOTOS. TWO (2) PHOTOS CONFIRMED THE PRESENCE OF FM IN A TOTAL OF 10 TUBES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS. A TOTAL OF 21 SAMPLES WERE RECEIVED. FOR LOT 6182782: ONE (1) TUBE WITH NO ADDITIVE. TWELVE (12) TUBES WITH FM IN GEL. ONE (1) DAMAGED/SCRATCHED TUBE. ONE (1) LOW GEL . FIVE (5) DAMAGED LABELS. ONE (1) MISSING LABEL. A TOTAL OF 20 SAMPLES WERE RECEIVED. FOR LOT 6245983: THREE (3) TUBES WITH GEL SMEAR. SEVEN (7) TUBES WITH FM IN GEL. SIX (6) DAMAGED/SCRATCHED TUBES. FOUR (4) DAMAGED LABELS. CONCLUSION: IT IS UNKNOWN IF IT WAS IN THE GEL AND CAME FROM GEL MANUFACTURING SITE OR WAS INTRODUCED IN THE TUBE AFTER THE FORMING PROCESS. THERE HAS BEEN INCREASED AWARENESS FOR CLEANLINESS AND REDUCTION OF FOREIGN MATTER IN THE PLANT. A NUMBER OF PROJECTS ARE IN PLACE THAT WILL HELP REDUCE THE POTENTIAL OF INTRODUCING FM INTO TUBES. A TEAM HAS ALSO BEEN ESTABLISHED THAT THE MAIN FOCUS IS FM AWARENESS AND REDUCTION. THE PEELER PLATE OR LABEL SENSOR WERE NOT ADJUSTED PROPERLY. OR THE LABEL WAS PARTIALLY LIFTED, SO IT COULD¿VE GOTTEN ATTACHED TO ANOTHER LABEL AND RIPPED. THE FM APPEARS TO BE DUST/DIRT. IT IS UNKNOWN IF IT WAS INTRODUCED DURING THE MANUFACTURING PROCESS OR DUE TO SUBSEQUENT SHIPPING. TUBES ARE FILLED WITH THE GEL AND DISPENSE WEIGHTS ARE VERIFIED PRIOR TO PRODUCTION AND EVERY HOUR IN-PROCESS. WHEN AIR IS INTRODUCED INTO THE LINES AND NOT PURGED THE TUBES WILL HAVE A LOW FILL. TUBES ARE HAND FILLED WITH ADDITIVE, ADVANCING THE DISPENSING NOZZLE TO THE NEXT UNFILLED TUBE WITH EACH PUMP CYCLE, IF PUMP SITS FOR LONGER THAN 10 MINUTES A PURGE NEEDS TO BE COMPLETED. IT IS POSSIBLE THAT HUMAN ERROR OCCURRED CAUSING THE TUBE TO NOT GET THE REQUIRED AMOUNT OF ADDITIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REGEN¿ THT® NC HAD FOREIGN MATTER ON TUBE CAP OR IN THE TUBE, ADDITIVE ISSUES, GEL ISSUES, SCRATCH MARKS, BROKEN TUBES, AND DAMAGED ETIQUETTES. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875316 REGEN¿ THT® NC BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. 6245983

    Patients

    Seq Age Sex Outcome Treatment
    1 Other