BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 20 ML SYRINGE

    MDR report key: 10705007 · Received October 20, 2020

    Report

    Report Number
    3002682307-2020-00316
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 15, 2020
    Report Date
    December 30, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-24. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2003251 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD. THROUGH MAGNIFIED INSPECTION, DAMAGE WAS OBSERVED TO THE PLUNGER ROD LIP COMPONENT. THIS TYPE OF DAMAGE CAN BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. DAMAGE TO THE PLUNGER LIP COMPONENT CAN RESULT IN LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD DISCARDIT¿ II 20 ML SYRINGE LEAKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECENTLY, WE HAVE OFTEN NOTICED THE LEAKAGE OF DISCARDIT SYRINGES 20ML (WHEN ASPIRATING).

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD DISCARDIT¿ II 20 ML SYRINGE LEAKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECENTLY, WE HAVE OFTEN NOTICED THE LEAKAGE OF DISCARDIT SYRINGES 20ML (WHEN ASPIRATING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173697 BD DISCARDIT II 20 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2003251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other