BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA

    MDR report key: 8497018 · Received April 9, 2019

    Report

    Report Number
    3002682307-2019-00238
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 11, 2019
    Report Date
    May 28, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLES FOR CATALOG 301948 LOT 1810138 TO INVESTIGATE FOR THIS RECORD. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN TWO OF THESE PROVIDED SAMPLES AFTER EVALUATION OF THE PLUNGER WITH MAGNIFICATION. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD BELIEVES THAT THE CAUSE OF THE PROBLEM COULD WAS PRODUCED BECAUSE 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. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING TAKING SOLUTION, IT WAS FOUND THAT SOLUTION LEAKED ALONG THE BARREL THROUGH THE PLUNGER TIP.

    Additional Manufacturer Narrative · 1

    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 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING TAKING SOLUTION, IT WAS FOUND THAT SOLUTION LEAKED ALONG THE BARREL THROUGH THE PLUNGER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287627 SYRINGE S2 20ML 18GA 1-1/2IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1810138

    Patients

    Seq Age Sex Outcome Treatment
    1 Other