BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 5ML SYRINGE

    MDR report key: 6902619 · Received September 28, 2017

    Report

    Report Number
    3002682307-2017-00053
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 6, 2017
    Report Date
    November 7, 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 RECEIVED THE INVESTIGATION CONCLUDED: 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. INVESTIGATION CONCLUSION: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. AFTER THE EVALUATION OF THE RETURNED SAMPLE, WE CONFIRMED THE REPORTED ISSUE, AND IDENTIFIED THE FOREIGN MATTER AS DIRT IN THE SHIELD OF THE NEEDLE. 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. SYRINGES WERE PACKED IN MACHINE Nº2020 (FEBRUARY 6 - 7TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4236, Nº4220, AND Nº4210, IN LOT #7030005 (JANUARY 30 - FEBRUARY 6TH, 2017) AND IN LOT #7034456 (FEBRUARY 6 - 13TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7031187, #7024019, AND #7034436 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7031191, #7024023, AND #7034436 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. ROOT CAUSE DESCRIPTION: THE AFFECTED SAMPLE WAS RETURNED FOR OUR EVALUATION. AFTER THE EVALUATION OF THE SAMPLE AND THE DISCUSSION WITH OUR PRODUCTION SUPERVISORS, WE HAVE DETERMINED THAT THE FOREIGN MATTER OF THE NON-CONFORMANCE CONSISTS OF A SMALL PIECE OF DIRT. THE DIRT IN THIS CASE CAME FROM THE ASSEMBLY MACHINE. IN THAT CASE, WE CONSIDER THAT BECAUSE OF A PUNCTUAL FAILURE IN THE CLEANING PROCEDURES BY THE OPERATOR, THE PRESENCE OF THIS PARTICLE IN THE MACHINE WAS PERMITTED DURING MANUFACTURING. ON THE OTHER HAND, BASED ON THE PREVENTIVE MEASURES AND OUR STRINGENT SAMPLING INSPECTION, WE ARE CONFIDENT THAT THIS HAS BEEN AN ISOLATED CASE AND ANY PROBABILITY OF OCCURRENCE SHOULD BE VERY EXCEPTIONAL. THE RETURNED AFFECTED SAMPLE PRESENTED CONTAMINATION IN THE SHIELD. WE CONFIRMED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE NEEDLE COVER OF A BD¿ 5ML SYRINGE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679544 BD¿ 5ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1702145

    Patients

    Seq Age Sex Outcome Treatment
    1 Other