BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II - 2-PIECE SYRINGE

    MDR report key: 16832596 · Received April 28, 2023

    Report

    Report Number
    2243072-2023-00666
    Event Type
    Malfunction
    Date Received
    April 28, 2023
    Date of Event
    March 31, 2023
    Report Date
    May 3, 2023
    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

    H6: INVESTIGATION SUMMARY: PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO FOR THE REPORTED COMPLAINTS OF MARKING DEFECT, WITHOUT SYRINGE FROM LOT NUMBER 2061254 REGARDING MATERIAL NUMBER 301866. THE PHOTOGRAPHS CONFIRMED THE REPORTED DEFECTS ON THE SYRINGE. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF LOT NUMBER 2061254 REGARDING MATERIAL NUMBER 301866 FOR INVESTIGATING THE REPORTED DEFECT. THE SAMPLES WERE VISUALLY TESTED, AND NO DEFECT WAS FOUND IN THE RETENTION SAMPLES. THE EXACT ROOT CAUSE CAN ONLY BE DETERMINED IF WE RECEIVE THE ORIGINAL SAMPLE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL, INDIA. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. E1: ENTER ADDRESS INFORMATION: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 289 OF THE BD DISCARDIT¿ II - 2-PIECE SYRINGE EXPERIENCED SCALE MARKING ISSUES. 1 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MARKING DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 289 OF THE BD DISCARDIT¿ II - 2-PIECE SYRINGE EXPERIENCED SCALE MARKING ISSUES. 1 OF 2. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MARKING DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046727 BD DISCARDIT¿ II - 2-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2061254

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown