BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP

    MDR report key: 8052234 · Received November 8, 2018

    Report

    Report Number
    3002682307-2018-00268
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    August 23, 2018
    Report Date
    November 16, 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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE OR PICTURE AVAILABLE FOR EVALUATION. DHR REVIEW FOR LOT # 1807277: 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 Nº2013 (JULY 29TH ¿ AUGUST 1ST, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4219, Nº4218, AND Nº4207, IN LOT #8204672 (JULY 23RD ¿ 30TH, 2018), LOT #8211653 (JULY 30TH - AUGUST 2ND, 2018), LOT #8197931 (JULY 18TH ¿ 23RD, 2018) AND LOT #8148570 (MAY 28TH - JUNE 4TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8205935, #8198685, #8185539, #8212968, AND 1 QN (#11029) RELATED TO DAMAGED BARREL AFFECTING FUNCTIONALITY WAS FOUND IN LOT #8185539 IN MACHINE Nº3545. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8205937, #8198688, #8142771, #8212969, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. THE MATERIAL USED TO MANUFACTURE EMERALD SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. BASED ON THE CUSTOMER FEEDBACK, THE DEFORMATION OF THE BARREL COULD BE PRODUCED DURING THE MANUFACTURING PROCESS DUE TO A DEFECTIVE MOLDING OF THE PIECE OR HARD CONDITIONS OF STORAGE AFTER INJECTION. WE HAVE FOUND ONE QUALITY NOTIFICATION RELATED TO INCORRECT MOLDING OF THE PIECE DUE TO A PROBLEM IN THE REFRIGERATION SYSTEM OF THE PRESS. OTHERWISE, 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 POSSIBILITY OF RECURRENCE IS LOW. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS LOW AND ANY RECURRENCE IS UNLIKELY IN OUR PRODUCTS, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP HAD A DAMAGED BARREL THAT COULD LEAD TO VOLUMETRIC INACCURACY. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    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 EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP HAD A DAMAGED BARREL THAT COULD LEAD TO VOLUMETRIC INACCURACY. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893367 BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP SYRINGE FMF BECTON DICKINSON, S.A. 1807277

    Patients

    Seq Age Sex Outcome Treatment
    1 Other