BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 7173079 · Received January 8, 2018

    Report

    Report Number
    2243072-2017-00426
    Event Type
    Malfunction
    Date Received
    January 8, 2018
    Date of Event
    December 14, 2017
    Report Date
    March 13, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). NO LOT # PROVIDED, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 11/28/17 VIA MEDWATCH #5073590. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: SAMPLE EVALUATION: ONE 10ML ASSEMBLED SYRINGE WAS RECEIVED BY BD CANAAN FROM AN UNKNOWN BATCH # AND MATERIAL #. IT WAS VISUALLY EVALUATED. IT HAD A DISTORTED STOPPER CONDITION, LIKELY DUE TO AN ERROR DURING ASSEMBLY PROCESS. DHR REVIEW COULD NOT BE PERFORMED DUE TO UNKNOWN BATCH #. ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD SYRINGE HAD A DEFORMED PLUNGER SEAL. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17615 UNSPECIFIED BD SYRINGE SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other