BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE

    MDR report key: 7342158 · Received March 15, 2018

    Report

    Report Number
    3002682307-2018-00050
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 19, 2018
    Report Date
    February 21, 2018
    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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION RESULTS: SUMMARY: AN INVESTIGATION WAS COMPLETE USING A PICTURE OF ONE AFFECT SAMPLE RETURNED FOR EXAMINATION. VISUAL INSPECTION OF THE SAMPLE REVEALED A BREAKAGE OF THE SYRINGE BARREL AND PLUNGER. BASED ON THESE FINDINGS, WE VERIFY THE REPORTED ISSUE. THE MATERIAL USED TO MANUFACTURE EMERALD SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100% OF THE SYRINGES, REJECTING AUTOMATICALLY THE SYRINGES WITH BROKEN PARTS LIKE THE PLUNGER. BASED ON THIS FACT, THE REPORTED NONCONFORMANCE WAS PRODUCED DUE TO SOME BLOCKAGE IN THE PRIMARY PACKAGING MACHINE FEEDER. SINCE THE MAGNITUDE OF THE DAMAGE IN THE SYRINGE IS SIGNIFICANT ENOUGH TO STOP THE MACHINE, REJECTING AUTOMATICALLY THE ONES WITH MAJOR DAMAGES, WE BELIEVE THAT THE ROOT CAUSE OF THE PROBLEM IS RELATED WITH A HUMAN ERROR. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CONCLUSION: SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH A PICTURE OF ONE AFFECTED SAMPLE. VISUAL INSPECTION OF THE SAMPLE REVEAL A BREAKAGE OF THE SYRINGE BARREL AND PLUNGER. THAT CONFIRMED THE REPORTED ISSUE. BHR REVIEW: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY WITH LOT #1708152. ASSOCIATED SYRINGE LOT #7237290; BARREL LOTS #7237231, #7234130, AND #7211173; AND PLUNGER LOTS #7237233, #7234131, #7211180, AND #7202249 REVEALED NO PROBLEMS, DEFECTS OR QNS RELATED TO THE REPORTED ISSUE. ROOT CAUSE: THE MATERIAL USED TO MANUFACTURE EMERALD SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100 % THE SYRINGES, REJECTING AUTOMATICALLY THE SYRINGES WITH BROKEN PARTS LIKE THE PLUNGER. BASED ON THIS FACT, THE REPORTED NON-CONFORMANCE WAS PRODUCED DUE TO SOME BLOCKAGE IN THE PRIMARY PACKAGING MACHINE FEEDER. SINCE THE MAGNITUDE OF THE DAMAGE IN THE SYRINGE IS SIGNIFICANT ENOUGH TO STOP THE MACHINE, REJECTING AUTOMATICALLY THE ONES WITH MAJOR DAMAGES, WE THINK THAT THE ROOT CAUSE OF THE PROBLEM IS RELATED WITH A HUMAN ERROR. THE RETURNED PICTURE OF THE SAMPLE PRESENTED THE REPORTED ISSUE. WE COULD CONFIRM 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 AN BD EMERALD¿ 5ML SYRINGE WAS FOUND "NOT MOLDED CORRECTLY" PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183399 BD EMERALD¿ SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1708152

    Patients

    Seq Age Sex Outcome Treatment
    1 Other