BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD PEN NEEDLE

    MDR report key: 2312766 · Received October 27, 2011

    Report

    Report Number
    9610847-2011-00087
    Event Type
    Injury
    Date Received
    October 27, 2011
    Date of Event
    July 20, 2011
    Report Date
    October 27, 2011
    Manufacturer
    BD MEDICAL - INFUSION THERAPY SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K060007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THREE DIFFERENT LOTS WERE RECEIVED, A FOLLOW-UP WAS CONDUCTED TO FIND OUT WHICH LOT WAS INVOLVED IN THE INCIDENT, HOWEVER, FACILITY COULD NOT IDENTIFY WHICH LOT THE DEFECTIVE SAMPLE CAME FROM. EVAL SUMMARY: ISSUE: NEEDLE STICK; SHIELD DOES NOT LOCK OUT. REGULATORY COMPLIANCE DID NOT RECEIVE THE ACTUAL SAMPLE INVOLVED IN INCIDENT, HOWEVER, RECEIVED THREE DIFFERENT LOTS: (101) SEALED 8MM, 29G AUTO SHIELD PEN NEEDLE WITH THE SHELF CARTON FROM LOT # 1006260, (9) SEALED 8MM, 29G AUTO SHIELD FROM LOT #0243177, AND (9) SEALED 8MM, 29 G AUTO SHIELD FROM LOT # 0243169. CUSTOMER STATES THAT SHE RECEIVED A NEEDLE STICK AND THE NEEDLE DID NOT RETRACT. TWENTY OUT OF 101 RECEIVED AUTO SHIELD PEN NEEDLES FROM LOT # 1006260 WERE EVALUATED AND WERE OBSERVED TO ENGAGE PROPERLY AND INJECT INSULIN WITHOUT ANY DEFECTS. TWO OUT OF NINE RECEIVED AUTO SHIELD PEN NEEDLES FROM EACH LOT# 0243177 AND 0243169 WERE ALSO EVALUATED AND WERE OBSERVED TO ENGAGE PROPERLY AND INJECT INSULIN WITHOUT ANY DEFECTS. THE NEEDLE NOT RETRACTING AND NEEDLE STICK ISSUES CANNOT BE CONFIRMED AS DEFECTS. NO FURTHER ACTION REQUIRED. COMPLAINT HISTORY CHECK WAS PERFORMED AND AS OF ((B)(6) 2011) YIELDED NO OTHER COMPLAINTS AGAINST LOT NUMBER 1006260, 0243177, 0243169 FOR SAME ISSUE. INFO WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY.

    Description of Event or Problem · 1

    MEDICAL PROFESSIONAL REPORTED STUDENT NURSE HAD BEEN IN-SERVICED ON THE PRODUCT. THE NEEDLE STICK OCCURRED WHEN SHE WAS WITHDRAWING THE NEEDLE AFTER INJECTING THE PT. NURSE HAS HAD (B)(6) AND HER TITER IN 2010 WAS IN RANGE. THE PT INVOLVED HAS HIS BLOOD WORK DRAWN. THE CLINICIAN WHO RECEIVED THE NEEDLE STICK WAS A STUDENT NURSE. SHE WENT TO THE ER AND HER FAMILY DOCTOR WHO BOTH SAID TO WAIT FOR THE PT'S BLOOD WORK BEFORE THEY MOVE FORWARD. NURSE WILL NOT RECEIVE PROPHYLAXIS OR BLOOD WORK UNTIL THE RESULTS ARE VIEWED. THE BLOOD WORK FROM THE PT CAME BACK (B)(6) THEREFORE THERE WAS NO TREATMENT OR BLOOD WORK REQUIRED FROM THE STUDENT NURSE INVOLVED IN THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD AUTOSHIELD PEN NEEDLE 29 GA X 8MM PEN NEEDLE FMI BD MEDICAL - INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other