BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ FC BEADS 7-COLOR KIT

    MDR report key: 9354657 · Received November 21, 2019

    Report

    Report Number
    2916837-2019-00110
    Event Type
    Injury
    Date Received
    November 21, 2019
    Date of Event
    October 14, 2019
    Report Date
    October 31, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    K170974
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PHONE NUMBER UNKNOWN. INVESTIGATION SUMMARY: SCOPE OF ISSUE OR PROBLEM STATEMENT: CUSTOMER COMPLAINT ON OPERATOR SCRATCHED THE CORNEA OF HIS EYE WHILE OPENING THE FOIL POUCH IS FOR 7- COLOR FC BEADS KIT 656867-9021747. MANUFACTURING DEFECT TREND: FROM 10/01/2018 TO 10/25/2019 THERE ARE NO QN¿S CREATED FOR MATERIAL 656867 KIT FC BEADS 7 COLOR CE/IVD RELATED TO FOIL POUCH ISSUE. COMPLAINT TREND: FROM 10/01/2018 TO 10/25/2019 THIS IS THE ONLY INVESTIGATION PIR ON CUSTOMER COMPLAINT - OPERATOR SCRATCHED THE CORNEA OF HIS EYE WHILE OPENING THE FOIL POUCH IN 7-COLOR FC BEADS KIT 656867-9021747. BATCH HISTORY RECORD REVIEW: REVIEWED BATCH RECORD AND MATERIAL PASSED SPECIFICATION UPON RELEASE FOR 656867-9021747. RESULT OF RETAIN SAMPLE TESTING: RETAIN TESTING NOT REQUIRED FOR INVESTIGATION. POUCHES ARE VALIDATED AND CHOSEN ACCORDING TO DESIGN TO PROTECT CRITICAL TO QUALITY ATTRIBUTES OF THE PRODUCT. RESULT OF RETURNED SAMPLE EVALUATION: NO SAMPLES REQUESTED. USED SAMPLES OF FC BEAD POUCH TO INVESTIGATE ISSUE. INVESTIGATION RESULT / ANALYSIS: REVIEWED BATCH RECORD FOR 656867-9081747 AND PRODUCT PASSED ACCEPTANCE CRITERIA PRIOR TO RELEASE. COMPLAINT IS NOT RELATED TO BEAD PERFORMANCE AND FUNCTION. POUCHES ARE VALIDATED AND CHOSEN ACCORDING TO DESIGN TO PROTECT CRITICAL TO QUALITY ATTRIBUTES OF THE PRODUCT. FOR EXAMPLE, LIGHT AND HUMIDITY MAY HAVE AN IMPACT TO PRODUCT QUALITY AND THE FOIL POUCH CONTROLS FOR THESE VARIABLES. THE INSTRUCTION FOR USE 23-15656-02 STATES ON PAGE 3 TO USE PERSONAL PROTECTIVE EQUIPMENT INCLUDING EYE PROTECTION. THE USE OF EYE PROTECTION WOULD PREVENT THIS TYPE OF EVENT FROM OCCURRING. RISK ANALYSIS: IN RESPONSE TO THIS REPORT, DESIGN FMEA 100161FMEA REV 05 WAS REVIEWED. THERE WAS NO RISK ADDRESSING THIS TYPE OF OCCURRENCE. 100161FMEA FMEA WAS UPDATED WITH RISK NUMBER 1.3.4 TO ASSESS THIS TYPE OF EVENT. BASED ON THE RISK ASSESSMENT THE RESIDUAL PROBABILITY (RP) IS 1 AND RESIDUAL SEVERITY (RS) IS 3 WITH RESIDUAL RISK INDEX (RRI) OF 3. THE DETERMINATION WAS THE RISK LEVEL WAS ACCEPTABLE GIVEN THE MITIGATION ALREADY IN PLACE REGARDING THE INSTRUCTION FOR USE STATEMENT TO USE EYE PROTECTION. 100161FMEA IS ADDED TO DHF 312. THE NEW REVISION OF THE FMEA IS UNDER EC0500000179526 WITH EFFECTIVITY DATE OF 13NOV2019. ROOT CAUSE: USER ERROR. CUSTOMER NOT USING PERSONAL PROTECTIVE EQUIPMENT AS NOTED IN THE INSTRUCTIONS FOR USE 23-15656-02 REV 01. CONCLUSION: THIS ISSUE IS NOT CONFIRMED AS A PRODUCT DEFECT. ATTACHED PICS/DOCS FROM INVESTIGATION: 100161FMEA REV 05 IS ATTACHED. INVESTIGATION CONCLUSION: THIS ISSUE IS NOT CONFIRMED AS A PRODUCT DEFECT. ROOT CAUSE DESCRIPTION: USER ERROR. CUSTOMER NOT USING PERSONAL PROTECTIVE EQUIPMENT AS NOTED IN THE INSTRUCTIONS FOR USE 23-15656-02 REV 01. RATIONALE: THE COMPLAINT SEVERITY WAS (S2). BASED ON THE EVALUATION OF COMPLAINT SEVERITY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE COMPLAINT WAS REVIEWED, AND NO ADVERSE EVENT HAS OCCURRED AT THIS TIME. NO NON-CONFORMANCE HAS OCCURRED. THIS COMPLAINT MODE WILL BE TRENDED, AND FURTHER INVESTIGATION WILL BE REQUIRED IF AN ACTIONABLE LEVEL IS REACHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE CONDUCTING IN-HOUSE TESTING ON BD¿ FC BEADS 7-COLOR KIT THAT ONE OF THE EMPLOYEES WENT TO CHANGE THE POUCH AND SCRATCHED THEIR CORNEA WITH THE POUCH. THEY HAD TO GO TO THE HOSPITAL TO RECEIVE EYE DROPS AND ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148634 BD¿ FC BEADS 7-COLOR KIT FLOW CYTOMETRIC REAGENTS AND ACCESSORIES OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 9021747

    Patients

    Seq Age Sex Outcome Treatment
    1 Other