BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 10 ML SYRINGE

    MDR report key: 10323438 · Received July 24, 2020

    Report

    Report Number
    3002682307-2020-00230
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    July 3, 2020
    Report Date
    November 3, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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: 2020-10-21. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 2003164 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 INSPECTION OF THE SAMPLE, LEAKAGE WAS OBSERVED THROUGH THE PLUNGER ROD COMPONENT. IT HAS BEEN DETERMINED THAT THE LEAKAGE RESULTED FROM DAMAGE TO THE PLUNGER ROD. THE PLUNGER ROD DAMAGE WAS IDENTIFIED THROUGH MICROSCOPIC EXAMINATION OF THE PLUNGER COMPONENT. THIS TYPE OF DAMAGE CAN BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCREDIT¿ II 10 ML SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE AT THE PLUNGER OF THE SYRINGE: LIQUID/ RUNS IN THE PLUNGER, IT CANNOT BE GUARANTEED THAT THE PATIENT IS TAKING THE CORRECT AMOUNT OF MEDICATION GETS.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II 10 ML SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE AT THE PLUNGER OF THE SYRINGE: LIQUID/ RUNS IN THE PLUNGER, IT CANNOT BE GUARANTEED THAT THE PATIENT IS TAKING THE CORRECT AMOUNT OF MEDICATION GETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783043 BD DISCARDIT II 10 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2003164

    Patients

    Seq Age Sex Outcome Treatment
    1 Other