BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE S/T W/NDL RB

    MDR report key: 8216486 · Received January 4, 2019

    Report

    Report Number
    1213809-2018-00982
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Date of Event
    December 19, 2018
    Report Date
    January 28, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN SECTION H.10 OF THE PREVIOUSLY SUBMITTED MDR, SECTIONS D.1 AND H.1 WERE INCORRECTLY REFERENCED AS THE MEDICAL DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THOSE REFERENCES TO SHOW THE FOLLOWING: MEDICAL DEVICE EXPIRATION DATE. DEVICE MANUFACTURE DATE. ADDITIONAL INFORMATION: MEDICAL DEVICE LOT #: 8059526. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-02-28.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE S/T W/NDL RB HAD DIFFICULT PLUNGER MOVEMENT BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGE S/T W/NDL RB HAD DIFFICULT PLUNGER MOVEMENT BEFORE USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 BD¿ SYRINGE S/T W/NDL RB HAD DIFFICULT PLUNGER MOVEMENT BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9309 BD¿ SYRINGE S/T W/NDL RB GENERAL-PURPOSE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8059526 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Other