BEUDAMED
    FDA Adverse Event Death Summary report: N

    3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 6001535 · Received October 5, 2016

    Report

    Report Number
    1213809-2016-00031
    Event Type
    Death
    Date Received
    October 5, 2016
    Date of Event
    September 20, 2016
    Report Date
    October 3, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR THESE LOT NUMBERS IS AS FOLLOWS: MEDICAL DEVICE LOT #: 3121212, MEDICAL DEVICE EXPIRATION DATE: 4/30/2018, DEVICE MANUFACTURE DATE: 05/01/2013. MEDICAL DEVICE LOT #: 5022712, MEDICAL DEVICE EXPIRATION DATE: 01/31/2020, DEVICE MANUFACTURE DATE: 01/22/2015. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE POTENTIAL REPORTED LOT NUMBERS 3121212 AND 5022712. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. ADDITIONALLY, OUR QUALITY ENGINEER NOTES THAT OTSUKA ABILITY MAINTENA IS SOLD IN KITS. EACH KIT CONTAINS PRODUCT FROM SEVERAL OTHER MANUFACTURES, WAJIKI, BAXTER, SMITHS, WEST AND BD. IT WAS NOTED IN CONVERSATIONS WITH OTSUKA THAT AT NO TIME WERE ANY INDIVIDUAL COMPONENTS OR THE PRODUCT IN GENERAL DIRECTLY IMPLICATED IN THE PATIENT'S DEATH. IT IS HIGHLY UNLIKELY THAT THE DEVICE IN QUESTION LEAD TO THE PATIENT'S UNFORTUNATE DEATH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE DIED OF HEAT STROKE. THE RELATION OF THE DEVICE TO THE PATIENT'S DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650947 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death