BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 7160827 · Received January 3, 2018

    Report

    Report Number
    3002682307-2017-00154
    Event Type
    Malfunction
    Date Received
    January 3, 2018
    Date of Event
    December 15, 2017
    Report Date
    February 2, 2018
    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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DATE RECEIVED BY MANUFACTURING: CHANGED/CORRECTED FROM 09/01/2017 TO 12/15/2017.

    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.

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED THE AFFECTED SAMPLES. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THIS PROVIDED SAMPLES. AFTER THAT WE COULD DETERMINATE A DAMAGED IN THE PLUNGER ROD BY THE EVALUATION OF THE PLUNGER WITH MAGNIFICATION. THE PRODUCTION AND INSPECTION RECORDS WERE REVIEWED AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. SYRINGES WERE ASSEMBLED IN MACHINE, Nº4253, Nº4235, Nº4213, Nº4212, AND Nº4203, IN LOT #7234166 (AUGUST 23 - 28TH, 2017) AND LOT #7244145 (SEPTEMBER 4 - 11TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. BARRELS LOTS #7244050, #7237224, #7234192, AND #7211166 HAVE BEEN REVIEWED AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. PLUNGER LOTS #7244051, #7237228, #7234196, #7211170, AND #7198289 AVE BEEN REVIEWED AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. CONCLUSION: ROOT CAUSE ANALYSIS IT WAS CONCLUDED THAT THE CAUSE OF THE PROBLEM WAS PRODUCED AS A CONSEQUENCE OF A DAMAGE IN THE PLUNGER LIP. THIS DAMAGED WAS PRODUCED IN THE ASSEMBLY MACHINE DUE TO AN UNEXPECTED MISALIGNMENT OF THE PLUNGER ASSEMBLY STATION. THE PROVIDED SAMPLES PRESENTED THE REPORTED ISSUE. WE COULD CONFIRM THE REPORTED ISSUE. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD DISCARDIT¿ II SYRINGE DURING USE OF THE SYRINGE, AIR PASSES IN SYRINGE. THE PLUNGER SEEMS TO BE SMALLER THAN THE BARREL OF SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3337 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1709126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other