BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP

    MDR report key: 8051744 · Received November 8, 2018

    Report

    Report Number
    3002682307-2018-00266
    Event Type
    Malfunction
    Date Received
    November 8, 2018
    Date of Event
    October 16, 2018
    Report Date
    December 4, 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: BD HAS BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. THE EVALUATION OF THE PICTURE PRESENTED A LEAKAGE BETWEEN TIP OF THE SYRINGE AND THE HUB OF THE NEEDLE. BD CONFIRMS THE REPORTED ISSUE. 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 NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8205937, #8198688, #8142771, #8212969, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BASED ON THE NONCONFORMANCE DESCRIPTION, BD BELIEVES THAT THE ISSUE COULD BE RELATED WITH SOME INEFFECTIVE LUER SLIP FITTING BETWEEN THE NEEDLE AND THE SYRINGE TIP. THIS COULD ALSO BE BECAUSE OF A DEFECTIVE LUER DIMENSIONS OR ANY DAMAGE IN THE PRODUCT. THE EXACT ROOT CAUSE FOR THIS ISSUE IS NOT POSSIBLE TO BE DETERMINE WITHOUT THE ACTUAL SAMPLE AVAILABLE. IN ADDITION, THIS COULD ALSO BE RELATED WITH THE ENGAGEMENT FORCE IF THE USER APPLIES VERY LOW FORCE. BD CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS ISOLATED AND ANY RECURRENCE IS UNLIKELY. SINCE REVIEW OF SYRINGE DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION AND SINCE THIS IS THE FIRST TIME THIS LOT IS REPORTED FOR THIS DEFECT, NO ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP LEAKED. NO SEROUS 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 LEAKED. NO SEROUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893269 BD EMERALD¿ SYRINGE, LUER SLIP CENTRIC TIP SYRINGE FMF BECTON DICKINSON, S.A. 1807277

    Patients

    Seq Age Sex Outcome Treatment
    1 Other