BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE HYPODERMIC NEEDLE 30G X 0.5" YELLOW ¿

    MDR report key: 6969848 · Received October 23, 2017

    Report

    Report Number
    3002682307-2017-00076
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 6, 2017
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K)#: THIS DEVICE DOES NOT HAVE A 510(K)#. INVESTIGATION SUMMARY. "RETURNED SAMPLE EVALUATION" EXAMINATION OF AFFECTED SAMPLE PICTURE SHOW WHITE DROP ON THE TIP OF CANNULA (METAL PART) WHICH CORRESPONDS TO EPOXY DROPS (GLUE USED TO JOIN CANNULA INTO HUB) ALONG THE CANNULA. THE DOSAGE OF EPOXY IS CORRECT. "LOT NUMBER / PRODUCT FAMILY HISTORY" COMPLAINT TRENDING REVIEW OF THIS LOT AND PRODUCT FAMILY IS NOT POSSIBLE TO PERFORM SINCE NO BATCH NUMBER HAS BEEN PROVIDED. INVESTIGATION CONCLUSION "DHR/BHR REVIEW" "WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. NEEDLES WERE PACKED IN MACHINE Nº2101 (MARCH 16-21ST, 2017) DURING WHICH 97 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLE WERE ASSEMBLED IN MACHINES Nº4412 AND COMES FORM 2 BATCHES: *7066137: (MARCH 13-21ST, 2017) DURING WHICH 351 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. *6292076: (OCTOBER 25-NOVEMBER 7TH, 2016) DURING WHICH 600 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. CANNULA BATCHES: 6158449, 6231408, 6075095, 6102282 AND 6075095." ROOT CAUSE DESCRIPTION. ROOT CAUSE. "THIS ISSUE OCCURRED IN THE ASSEMBLY PROCESS IN WHICH THE ADHESIVE IS ADDED TO THE HUB, PROBABLY BECAUSE OF SOME TEMPORARY STOPPAGE IN THE PROCESS OR ANY DES ADJUSTMENT OF THE EPOXY DOSAGE MACHINE. AS A CONSEQUENCE, HIGHER QUANTITY OF EPOXY WAS ADDED TO AND FELT DOWN THE HUB RESULTING IN THE OBSERVED ISSUE. BASED ON OUR EXPERIENCE, THE PROBABILITY OF OCCURRENCE OF THIS NON-CONFORMANCE SHOULD BE VERY LOW SUPPORTED BY THE LOW PERCENTAGE OF DEFECTS IDENTIFIED IN OUR ROUTINE IN-PROCESS INSPECTIONS." "CAPA DETERMINATION RESULTS" NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND IN A BD MICROLANCE¿ 3 NEEDLE 30G X 0.5. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747439 BD MICROLANCE HYPODERMIC NEEDLE 30G X 0.5" YELLOW ¿ HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 170321

    Patients

    Seq Age Sex Outcome Treatment
    1 Other