BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE 30G X 0.5"

    MDR report key: 5876622 · Received August 15, 2016

    Report

    Report Number
    3002682307-2016-00011
    Event Type
    Injury
    Date Received
    August 15, 2016
    Date of Event
    August 3, 2016
    Report Date
    August 26, 2016
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K): THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. RESULTS: IT IS UNKNOWN WHETHER A SAMPLE WILL BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE BRAND NAME WAS GIVEN INCORRECTLY IN THE ORIGINAL MDR. THE CORRECTED BRAND NAME SHOULD READ "BD MICROLANCE¿ HYPODERMIC NEEDLE 30G X 0.5" "

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED POTENTIAL LOTS #151127 AND #151128. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT REQUIRED SURGICAL INCISION TO REMOVE A BROKEN-OFF NEEDLE FROM HIS PENIS. THE PATIENT, A "LONG TIME" USER OF CAVERJECT, WAS ATTEMPTING TO SELF-INJECT A DOSE OF CAVERJECT AND "WHEN HE APPLIED ON HIS PENIS THE NEEDLE BROKE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528406 BD MICROLANCE¿ HYPODERMIC NEEDLE 30G X 0.5" HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention