BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML

    MDR report key: 11715909 · Received April 23, 2021

    Report

    Report Number
    3003152976-2021-00228
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    30382903006138
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D.10. RETURNED TO MANUFACTURER ON: 4/21/2021. H.6. INVESTIGATION: TWO SEALED SAMPLES OF LOT 2011052 WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND THE TIPS WERE OBSERVED NOT TO BE STRAIGHT, VERIFYING THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2011052, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS, HOWEVER, A DAILY INCIDENT REPORT DID IDENTIFY AN ISSUE RELATED TO PRODUCT JAMMING DURING THE MARKING PROCESS. ONCE DETECTED, THE MECHANICAL TEAM REPAIRED THE FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD SYRINGE 20ML THE TIP OF SYRINGE WAS BENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TIP OF THE SYRINGE IS NOT STRAIGHT BEFORE USE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD SYRINGE 20ML THE TIP OF SYRINGE WAS BENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE TIP OF THE SYRINGE IS NOT STRAIGHT BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612457 BD SYRINGE 20ML PISTON SYRINGE FMF BECTON DICKINSON, S.A. 300613 2011052 30382903006138

    Patients

    Seq Age Sex Outcome Treatment
    1