BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE

    MDR report key: 6853369 · Received September 8, 2017

    Report

    Report Number
    3002682307-2017-00042
    Event Type
    Malfunction
    Date Received
    September 8, 2017
    Date of Event
    July 3, 2017
    Report Date
    October 24, 2017
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BASED ON THE SAMPLE / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE A CAPA IS NOT REQUIRED AT THIS TIME. INVESTIGATION CONCLUSION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLES. VISUAL INSPECTION OF RETURNED AFFECTED SAMPLE REVEALED A PIECE OF PIN RACK IN HUB COMING FROM THE ASSEMBLING NEEDLE MACHINE. 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. SYRINGES WERE PACKED IN MACHINE Nº2011 (SEPTEMBER 24 - 25TH, 2016). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #6259458 (SEPTEMBER 18 - 26TH, 2016). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #6259457, AND #6249468 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #6264125, AND #6253447 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE DESCRIPTION: IN ORDER TO MOVE THE PIECES THROUGH THE ASSEMBLING PROCESS, THE NEEDLES ARE LOCATED IN SOME PLASTIC RACKS MADE OF GREEN POLYCARBONATE. BASED ON THE REPORTED ISSUE, OUR OPINION IS THAT ONE OF THESE "RACK PINS" MAY BREAK AS A CONSEQUENCE OF ANY BLOCKAGE IN THE MANUFACTURING PROCESS REMAINING ATTACHED TO THE NEEDLE. BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING PROCEDURES, WE ARE CERTAIN THAT THIS HAS BEEN AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY. CONFIRMATION: THE RETURNED AFFECTED SAMPLES PRESENTED A PIN RACK INSIDE THE HUB OF THE NEEDLE. WE CONFIRMED THE REPORTED ISSUE. CAPA DETERMINATION: NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLUE FOREIGN MATTER WAS FOUND IN A BD 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633288 BD 20 ML SYRINGE WITH 18G X 1.5 IN. NEEDLE HYPODERMIC SYRINGE W/ NEEDLE FMF BECTON DICKINSON, S.A. 1609254

    Patients

    Seq Age Sex Outcome Treatment
    1 Other