BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE WITH NEEDLE

    MDR report key: 9294331 · Received November 8, 2019

    Report

    Report Number
    3002682307-2019-00599
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 23, 2019
    Report Date
    December 11, 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 SUMMARY: BD WAS PROVIDED WITH A SAMPLE FOR CATALOG: 301948 LOT: 1812204 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE SAMPLE PRESENTED A LEAKAGE WITH THE SAMPLE. IT WAS DETERMINED THAT THERE WAS DIRECT DAMAGE TO THE PLUNGER ROD AFTER FURTHER EXAMINATION WAS DONE MICROSCOPICALLY. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. THE DAMAGE 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 CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ 20 ML SYRINGE WITH NEEDLE LEAKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON OCTOBER 21, 2019, REP. RECEIVED A COMPLAINT FROM HEAD NURSE OF HOSPITAL, WHO REPORTED THAT THE SYRINGE WAS LEAKING DURING THE SUCTION OF THE LIQUID.

    Additional Manufacturer Narrative · 1

    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¿ 20 ML SYRINGE WITH NEEDLE LEAKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, REP. RECEIVED A COMPLAINT FROM HEAD NURSE OF HOSPITAL, WHO REPORTED THAT THE SYRINGE WAS LEAKING DURING THE SUCTION OF THE LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088611 BD 20 ML SYRINGE WITH NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1812204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other