BEUDAMED
    FDA Adverse Event Injury Summary report: N

    31G X 8MM BD PEN NEEDLE

    MDR report key: 2042118 · Received March 30, 2011

    Report

    Report Number
    9616656-2011-00013
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ISSUE: INJURY. EVAL SUMMARY: REGULATORY COMPLIANCE RECEIVED (6) 8MM, 31G PEN NEEDLES (4 OPEN WITHOUT THE TEAR DROP LABEL OR INNER SHIELD AND 2 SEALED) FROM LOT # 9034821. CUSTOMER STATES THAT THE NEEDLES ARE BENDING WHEN INJECTING INTO THE STOMACH, AND SHE IS BLEEDING AND GETTING KNOTS. ALL RECEIVED PEN NEEDLES WERE EXAMINED, ALL 4 OPEN SAMPLES EXHIBITED A BENT IV END OF THE CANNULA. BOTH SEALED SAMPLES WERE EVALUATED FOR POINT GEOMETRY, LUBRICATION, AND CANNULA OUTER DIAMETER. ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. CANNOT CONFIRM DEFECT. NO FURTHER ACTION REQUIRED. COMPLAINT HISTORY CHECK WAS PERFORMED AND AS OF ((B)(6) 2011), YIELDED NO OTHER COMPLAINTS AGAINST LOT # 9034821 FOR SAME ISSUE. INFO WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT NEEDLES ARE BENDING WHEN INJECTING INTO STOMACH AND IS BLEEDING AND GETTING KNOTS/SPOTS. LATER, CONSUMER NOTIFIED THAT SHE HAS BEEN GOING TO THE DERMATOLOGIST TO RECEIVE TREATMENT FOR KELOID LIKE INJURIES THAT ARE CAUSING HER PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 31G X 8MM BD PEN NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON NA 9034821

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention| S