BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCARDIT¿ II SYRINGE W/O NEEDLE

    MDR report key: 7606329 · Received June 15, 2018

    Report

    Report Number
    3002682307-2018-00146
    Event Type
    Malfunction
    Date Received
    June 15, 2018
    Date of Event
    May 29, 2018
    Report Date
    July 25, 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: NO SAMPLES OR PHOTOS WERE RETURNED FOR EVALUATION. 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 Nº2022 (JANUARY 24TH - 25TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, Nº4208, AND Nº4204, IN LOT #8022706 (JANUARY 22ND ¿ 29TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8022720, #8015781, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8022724, AND #8015645 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BASED ON THE CUSTOMER FEEDBACK OF THE ISSUE, WE CONCLUDE THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. WE WERE NOT ABLE TO DETERMINE A ROOT CAUSE. DAMAGE IN THE PLUNGER LIP PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING A DISCARDIT¿ II SYRINGE W/O NEEDLE, IT LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE REPORTED LOT # 1801218 WAS NOT FOUND FOR THE REPORTED CAT #. INITIAL REPORTER PHONE#: (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 WHEN USING A DISCARDIT¿ II SYRINGE W/O NEEDLE, IT LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446805 DISCARDIT¿ II SYRINGE W/O NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other