BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2ML BD SYRINGE¿ WITH NEEDLE

    MDR report key: 7635180 · Received June 25, 2018

    Report

    Report Number
    3002682307-2018-00151
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    June 2, 2018
    Report Date
    August 27, 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
    CH
    Reporter Occupation
    NURSE

    Narratives

    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: DEVICE RETURNED TO MANUFACTURE: YES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WE HAVE BEEN PROVIDED WITH THE AFFECTED SAMPLES. WE HAVE CARRIED OUT A LEAKAGE TEST AND DETERMINE THAT THE SAMPLES DID NOT PRESENT THE REPORTED DEFECT. WE COULD NOT CONFIRM 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 PACKED IN MACHINE Nº2025 (FEBRUARY 17TH - 19TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4239, Nº4238, Nº4214, Nº4206, AND Nº4201, IN LOT #7041325 (FEBRUARY 13TH ¿ 20TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7041287, #7034435, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7041292, AND #7034439 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. AFTER THE EVALUATION OF THE RECEIVED SAMPLE, WE COULD NOT DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE. WE THINK 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 CAN ENSURE THAT THE PROBABILITY OF FINDING THIS KIND OF DEFECT IS AN ISOLATED ISSUE AND ANY RECURRENCE IS VERY 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 MEDICATION LEAKED FROM THE TIP OF A 2ML BD SYRINGE¿ WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MEDICATION LEAKED FROM THE TIP OF A 2ML BD SYRINGE¿ WITH NEEDLE. 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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICATION LEAKED FROM THE TIP OF A 2ML BD SYRINGE¿ WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475181 2ML BD SYRINGE¿ WITH NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1702201

    Patients

    Seq Age Sex Outcome Treatment
    1 Other