BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE S2 5ML 22GA 1-1/4IN

    MDR report key: 8717065 · Received June 20, 2019

    Report

    Report Number
    3002682307-2019-00368
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 16, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD WAS NOT PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 301942 LOT 1811192 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD IS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD BE 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. 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 BD¿ SYRINGE S2 5ML 22GA 1-1/4IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S FOUND LIQUID LEAKAGE AT THE TIP OF PLUNGER AND BARREL, SAMPLE NOT SAVED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ SYRINGE S2 5ML 22GA 1-1/4IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S FOUND LIQUID LEAKAGE AT THE TIP OF PLUNGER AND BARREL, SAMPLE NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508444 BD SYRINGE S2 5ML 22GA 1-1/4IN SYRINGE FMF BECTON DICKINSON, S.A. 1811192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other