BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 15233991 · Received August 16, 2022

    Report

    Report Number
    2243072-2022-01349
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 21, 2022
    Report Date
    August 25, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONSMFR SITE, AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THERE ARE NO SAMPLES AND TWO PHOTOGRAPH FROM THE CUSTOMER ALONG WITH THE REPORTED COMPLAINT OF LEAKAGE. THE DEFECT CANNOT BE CONFIRMED ON THE PHOTOGRAPH AS IT IS A FUNCTIONAL TEST AND THE ORIGINAL SAMPLE WILL BE NEEDED TO INVESTIGATE AND CONFIRM THE REPORTED DEFECT. THE INVESTIGATION OF PROBABLE ROOT CAUSE COULD ONLY BE CARRIED OUT ON THE ORIGINAL SAMPLE, WHICH WAS NOT AVAILABLE. THE INVESTIGATION IS THEREFORE INCONCLUSIVE. THE DHR OF MATERIAL NO. 300847 WITH BATCH NO. 2103036 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NO. FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD DISCARDIT II SYRINGE HAD AN ISSUE WITH THE LEAKAGE WHILE DRAWING SPINAL FLUIDS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCARDIT 5ML(24G) WAS AN ISSUE WITH THE LEAKAGE WHILE DRAWING SPINAL FLUIDS FROM THE PATIENT AND NO PATIENTS OR HCP WAS NOT AFFECTED WITH THE INCIDENT AND ASKED THE RESPECTIVE COMPANY PERSON TO RECTIFY THE ISSUE HAPPENED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD DISCARDIT II SYRINGE HAD AN ISSUE WITH THE LEAKAGE WHILE DRAWING SPINAL FLUIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCARDIT 5ML(24G) WAS AN ISSUE WITH THE LEAKAGE WHILE DRAWING SPINAL FLUIDS FROM THE PATIENT AND NO PATIENTS OR HCP WAS NOT AFFECTED WITH THE INCIDENT AND ASKED THE RESPECTIVE COMPANY PERSON TO RECTIFY THE ISSUE HAPPENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237734 BD DISCARDIT II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2103036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown