BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD CUSTOM KIT

    MDR report key: 1271244 · Received December 24, 2008

    Report

    Report Number
    1211998-2008-00002
    Event Type
    Injury
    Date Received
    December 24, 2008
    Date of Event
    November 10, 2008
    Report Date
    December 11, 2008
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    KYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TESTING WAS INCONCLUSIVE AND ADDITIONAL KITS WITH SIMILAR COMPONENTS WILL BE TESTED. IT IS NOT CLEAR AT THIS TIME IF BD PRODUCT WAS AT FAULT.

    Description of Event or Problem · 1

    NOTIFIED FROM CUSTOMER IN 2008 THAT DLK OCCURRED AFTER PERFORMING LASIK SURGERY WITH THE BD CUSTOMEYES KIT 584492. IT IS UNCLEAR AT THIS POINT WHICH COMPONENT IF ANY WAS THE ROOT CAUSE. IT WAS INDICATED BY THE BD SALES REP THAT THE CUSTOMER STATED THE IRRIGATING CANNULA CONTAINED WITHIN THE KIT WAS NOT USED. INSTEAD, A REUSABLE CANNULA WAS PREFERRED BY THE SURGEON. TEN LOTS WERE RETURNED BY THE CUSTOMER FOR EVALUATION. ALL RETURNED LOTS WERE FORWARDED TO A MICROBIOLOGY LAB AT BD CANAAN, CT. BD CANAAN WILL PERFORM ENDOTOXIN TESTING OF ALL COMPONENTS WITHIN EACH KIT. COMPONENTS IN THE KIT AREA: 1 1 BD VISITEC EXPANDED SPEAR (PACK OF 2) CAT# 581709, 1 BD PLASTIPAK 3ML LUER LOCK SYRINGE CAT# 301073, 1 BD VISITEC LASIK IRRIGATING CANNULA CAT# 585250, 2 EYE SPONGE (5/PK) CAT# 28054BID, 1 CSR PLASTIC WRAP (30" X 30") CAT# 100078SAR, 4 4X4 GAUZE SWABS CAT# 100065SAR, 1 GLOVES - LATEX FREE AND POWDER FREE CAT# 8020575.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD CUSTOM KIT CUSTOMEYES KIT KYG BECTON DICKINSON AND COMPANY NA 6324420

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention