BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NEEDLE

    MDR report key: 1030009 · Received April 9, 2008

    Report

    Report Number
    9616656-2008-00003
    Event Type
    Injury
    Date Received
    April 9, 2008
    Date of Event
    February 29, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ISSUE: CANNULA BREAK OFF - PEN NEEDLE. REGULATORY COMPLIANCE RECEIVED (1) LOOSE PEN NEEDLE HUB WITH NO TEAR DROP LABEL ALONG WITH A BROKEN OFF CANNULA. THE SAMPLE AS SUBMITTED INCLUDED THE HUB AREA OF THE FAILED PEN NEEDLE, AS WELL AS THE FRACTURED FREE AND ENCLOSED INSIDE BODY TISSUE/SKIN. THE COMPLAINT LAB PERFORMED EVALUATION FOR FAILURE ANALYSIS. MICROSCOPIC EXAMINATION OF THE SAMPLE WAS PERFORMED WITH LOW POWER OPTICAL MICROSCOPE. THIS EXAMINATION REVEAL CHARACTERISTICS SUCH AS CRACKED EPOXY, SLIGHT RESIDUAL BENDS, AND TUBING OVALITY, WHICH ALL ARE SUPPORTIVE INDICATORS OF BENDING/RESTRAIGHTENING MODE OF FAILURE. REMOVAL OF SOME OF THE EPOXY MADE THIS OBSERVATION MORE APPARENT. BASED ON THE HISTORY OF THE COMPLAINT THE CRIMPING/TOOL MARKS THAT ARE PRESENT ON THE BEVEL AREA OF THE FREE END MAY LIKELY BE THE RESULT OF THE SURGICAL REMOVAL OF THE BROKEN PIECE. THE ABSENCE OF ANY OBVIOUS MFG RELATED DEFECTS SUGGESTS A POTENTIAL USER RELATED ISSUE. NO INFO RELATING TO THE LOT NUMBER WAS RECEIVED FOR PRODUCT. COMPLAINT HISTORY CHECK WAS PERFORMED FOR THE LAST TWO YEARS AND AS OF 2008 YIELDED NO OTHER COMPLAINTS AGAINST CATALOG NUMBER 320632 FOR SAME ISSUE. FIVE (5) OTHER COMPLAINTS WERE FOUND FOR UNRELATED ISSUES. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    MOTHER OF CHILD REPORTS PERFORMING HORMONE GROWTH INJECTION ON CHILD IN THE BELLY FOR THE FIRST TIME. THE CHILD INDICATED THAT THE INJECTION WAS VERY PAINFUL AND WHEN THE MOTHER REMOVED THE PEN NEEDLE SHE FOUND THAT THE NEEDLE HAD BROKEN OFF. CHILD WAS TAKEN TO HOSP AND BROKEN OFF NEEDLE WAS REMOVED BY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R