BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD

    MDR report key: 8280466 · Received January 27, 2019

    Report

    Report Number
    3002682307-2019-00107
    Event Type
    Malfunction
    Date Received
    January 27, 2019
    Date of Event
    January 8, 2019
    Report Date
    February 1, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH ONE SAMPLE OF LOT 180721. REVIEW OF PRODUCTION AND INSPECTION RECORDS HAS ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S WERE FOUND. NEEDLES WERE PACKED IN MACHINE 2103 (OCTOBER 29-31ST, 2018) DURING WHICH 53 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECT NOTED. ASSEMBLED NEEDLES COME FORM 2 BATCHES: #8289644 (OCTOBER 21-30TH, 2018) ASSEMBLED IN MACHINE Nº4407 DURING WHICH 405 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO REJECTIONS NOTED. RE-WORK ORDER R-1810001 WHICH COMES FROM ASSEMBLED BATCH #8260635 (SEPTEMBER 21-27TH, 2018) ASSEMBLED IN MACHINE Nº4408 DURING WHICH 270 VISUAL INSPECTION WERE PERFORMED OF 25 UNITS EACH WITH 0 REJECTIONS NOTED. INVESTIGATION CONCLUSION: VISUAL INSPECTION SHOWS RESIDUE OF EPOXY (ADHESIVE USED TO JOIN CANNULA ¿METAL PART- WITH HUB ¿RED PLASTIC PART-) LOCATED ON THE TOP OF CANNULA. BASED ON ABOVE RESULTS, BD DETERMINED THE FOREIGN MATTER DETECTED BY CUSTOMER IS EPOXY (ADHESIVE USED TO JOIN METAL PART WITH NEEDLE PLASTIC PART - HUB). TAKING INTO ACCOUNT 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. ROOT CAUSE DESCRIPTION: 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 READJUSTMENT OF THE EPOXY DOSAGE MACHINE. AS A CONSEQUENCE, HIGHER QUANTITY OF EPOXY WAS ADDED TO AND FELT DOWN TO NEXT CANNULA RESULTING IN THE OBSERVED ISSUE. RATIONALE: BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE. ANY RECURRENCE IS UNLIKELY IN OUR PRODUCTS SINCE THE REVIEW OF NEEDLE DHR REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT. SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD HAD FOREIGN MATTER IN THE NEEDLE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BD¿ NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD HAD FOREIGN MATTER IN THE NEEDLE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73120 BD NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD SYRINGE FMF BECTON DICKINSON, S.A. 181021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other