BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 21X1-1/2 RB TW

    MDR report key: 9700199 · Received February 12, 2020

    Report

    Report Number
    8041187-2020-00075
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Date of Event
    January 13, 2020
    Report Date
    March 13, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057659
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY ONE PHOTO AND TWENTY-FIVE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE PHOTO, IT WAS OBSERVED THAT THERE WAS DAMAGED SEALING ON TWO UNIT PACKAGES AND DAMAGE HUB COMPONENT IN ONE UNIT PACKAGE. ALL OF THE SAMPLES WERE SUBJECTED TO INSPECTION TO CHECK ON THE SEALING AND DAMAGE COMPONENT. THE TEAM OBSERVED DAMAGED SEALING IN THE MIDDLE OF THE STRIP OF FIVE FOR ALL OF THE SAMPLES AND OBSERVED DAMAGED HUB ON (B)(4) SAMPLES AND DAMAGED SAFETY SHIELD ON (B)(4) SAMPLE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. THE SECONDARY PACKAGING PROCESS WAS REVIEWED. BASED ON THE SAMPLE EVALUATION, THE DAMAGED OCCURS AT ONLY THE MIDDLE PRODUCT WITHIN THE STRIP. THE DAMAGE COULD HAVE HAPPENED DURING PRODUCT INSERTION TO THE SHELF CARTON. THERE ARE THREE GRIPPERS AT THE TOP AND BOTTOM TO GUIDE THE PRODUCT INTO THE SHELF CARTON. THE GRIPPER COULD HAVE BEEN BENT WHERE THIS BEND GRIPPER EVENTUALLY HITS THE PART CAUSING DAMAGE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 21X1-1/2 RB TW PRIOR TO USE PACKAGING WAS DAMAGED AND AFFECTED STERILITY OF NEEDLE. THERE WERE (B)(4) DIFFERENT OCCURANCES. ¿MATERIAL NO.: 305765 BATCH NO.: 8171369 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: DAMAGED NEEDLE PACKS OPENED. DURING THE PACKAGING CL0537 ON (B)(6)2020 , NEEDLE (B)(4) GAUGE 1 1/2" BD ECLIPSE (B)(4) NEEDLE SLEEVES WERE NOTED TO HAVE DAMAGE TO THE NEEDLE AND THE TYVEK POUCH WAS OPENED. THE DEFECT IS SUCH THAT IT QUESTIONS THE STERILITY OF THE PRODUCT RECEIVED FROM BD. REQUESTS A FORMAL BD INVESTIGATION INTO THIS DEFECT.¿.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEEDLE ECLIPSE 21X1-1/2 RB TW PRIOR TO USE PACKAGING WAS DAMAGED AND AFFECTED STERILITY OF NEEDLE. THERE WERE 15 DIFFERENT OCCURENCES. ¿MATERIAL NO.: 305765, BATCH NO.: 8171369. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: DAMAGED NEEDLE PACKS OPENED. DURING THE PACKAGING (B)(4) ON (B)(6) 2020, NEEDLE 21 GAUGE 1 1/2" BD ECLIPSE 5 NEEDLE SLEEVES WERE NOTED TO HAVE DAMAGE TO THE NEEDLE AND THE TYVEK POUCH WAS OPENED. THE DEFECT IS SUCH THAT IT QUESTIONS THE STERILITY OF THE PRODUCT RECEIVED FROM BD. REQUESTS A FORMAL BD INVESTIGATION INTO THIS DEFECT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166963 BD NEEDLE ECLIPSE 21X1-1/2 RB TW ECLIPSE NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305765 8171369 30382903057659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other