BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7659298 · Received July 3, 2018

    Report

    Report Number
    3002682307-2018-00156
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    May 22, 2018
    Report Date
    August 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLE. VISUAL INSPECTION OF THE RETURNED SAMPLE PRESENTED THE TIP BROKEN. THAT CONFIRMED THE REPORTED ISSUE. 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 PACKAGED IN MACHINE Nº2020 (FEBRUARY 4TH ¿ 5TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4255, Nº4254, Nº4237, Nº4236, AND Nº4220, IN LOT #8036711 (FEBRUARY 5TH - 12TH, 2018) AND IN LOT #8029657 (JANUARY 29TH ¿ FEBRUARY 5TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8030575, #8022718, #8037756, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8030579, #8022722, #8015643, AND #8037763 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 THE USE OR SOME STRONG CONDITION DURING HANDLING OR USE OF THE PRODUCT. WE CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY IN OUR PRODUCTS SINCE REVIEW 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF A BD DISCARDIT¿ II SYRINGE WAS NOTICED TO BE BROKEN WHILE INJECTING LIQUID. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF A BD DISCARDIT¿ II SYRINGE WAS NOTICED TO BE BROKEN WHILE INJECTING LIQUID. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THE TIP OF A BD DISCARDIT¿ II SYRINGE WAS NOTICED TO BE BROKEN WHILE INJECTING LIQUID. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499675 BD DISCARDIT¿ II SYRINGE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1802147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other