BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7570651 · Received June 5, 2018

    Report

    Report Number
    3002682307-2018-00139
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 18, 2018
    Report Date
    June 11, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAS NOT BEEN PROVIDED WITH A PICTURE OR SAMPLE TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD IS NOT ABLE TO VERIFY THE REPORT ISSUE. 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 Nº2020 (APRIL 9TH - 10TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE Nº4255, Nº4254, Nº4237, Nº4236, Nº4220, AND Nº4210, IN LOT #8085766 (APRIL 3RD - 9TH, 2018), AND IN LOT #8099687 (APRIL 9TH - 16TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8099991, #8085747, #8075985, AND #8072876, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. THE MATERIAL USED TO MANUFACTURE DISCARDIT 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 TIP OF THE BARREL. BASED ON THIS FACT, WE THINK THAT THE SYRINGE TIP COULD BREAK AS A CONSEQUENCE OF ANY IMPERCEPTIBLE DAMAGE IN THE BARREL AT THE MOMENT OF USE OR SOME STRONG CONDITION DURING HANDLING OR USE OF THE PRODUCT. INVESTIGATION CONCLUSION: NO SAMPLE RETURNED FOR EVALUATION. WE COULD NOT CONFIRM THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD DISCARDIT¿ II SYRINGE MALFUNCTIONED AS "WHEN USING A 5ML SYRINGE TO PURGE THE ARTERIAL CATHETER, THE TIP OF THE SYRINGE BROKE IN THE CLAVE ADAPTOR." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410376 BD DISCARDIT¿ II SYRINGE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1804137

    Patients

    Seq Age Sex Outcome Treatment
    1 Other