BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA

    MDR report key: 8510783 · Received April 12, 2019

    Report

    Report Number
    3002682307-2019-00250
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 28, 2019
    Report Date
    June 5, 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

    INVESTIGATION: BD HAS BEEN PROVIDED WITH THE AFFECTED SAMPLE FOR CATALOG 301945 LOT 1811101 TO INVESTIGATE FOR THIS RECORD. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THE PROVIDED SAMPLE. AFTER THAT BD COULD DETERMINE A DAMAGED IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD CONCLUDES THAT THE CAUSE OF THE PROBLEM 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 THERE WAS LEAKAGE ALONG INNER WALL OF BARREL THROUGH TIP OF PLUNGER WITH A BD SYRINGE¿ S2 10ML 22GA 1-1/4IN BD CHINA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: DURING TAKING SOLUTION, IT WAS FOUND THAT LEAKAGE ALONG THE INNER WALL OF BARREL THROUGH THE TIP OF PLUNGER.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: 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 THERE WAS LEAKAGE ALONG INNER WALL OF BARREL THROUGH TIP OF PLUNGER WITH A BD SYRINGE¿ S2 10ML 22GA 1-1/4IN BD CHINA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DURING TAKING SOLUTION, IT WAS FOUND THAT LEAKAGE ALONG THE INNER WALL OF BARREL THROUGH THE TIP OF PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304986 BD SYRINGE S2 10ML 22GA 1-1/4IN BD CHINA SYRINGE FMF BECTON DICKINSON, S.A. 1811101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other