BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP

    MDR report key: 7296532 · Received February 26, 2018

    Report

    Report Number
    3002682307-2018-00031
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    January 22, 2018
    Report Date
    March 5, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: N/A. BHR REVIEW WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE (B)(4) (JULY 6 - 8TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE (B)(4), IN LOT #7187063, #7083155, #7076204, AND 7160167. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7187033, #7160140, #77083124, #7055064, #7062452, #7076180, #7072489, AND #7062452, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. INVESTIGATION CONCLUSION: ROOT CAUSE ANALYSIS: 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 DAMAGED PARTS LIKE THE TIP OF THE BARREL. BASED ON THIS FACT, WE THINK THAT THE SYRINGE TIP COULD BROKE CAUSED BY SOME INAPPROPRIATE HANDLING CONDITION OR TRANSPORT OF THE PRODUCT BEFORE USE. CONFIRMATION: NO PICTURE OR SAMPLE RETURNED FOR EVALUATION. NO ISSUES FOUND IN THE BHR REVIEW. WE COULD NOT 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.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP BROKE OFF DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141190 BD EMERALD¿ 2ML SYRINGE, LUER SLIP CENTRIC TIP SYRINGE FMF BECTON DICKINSON, S.A. 1707155

    Patients

    Seq Age Sex Outcome Treatment
    1 Other