BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SYRINGE

    MDR report key: 3122012 · Received May 16, 2013

    Report

    Report Number
    2243072-2013-00054
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    March 29, 2013
    Report Date
    May 16, 2013
    Manufacturer
    BD
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED DUE TO THE CONSUMER HAVING TO RECEIVE A TETANUS VACCINATION. THE (B)(4) RECOMMENDS THAT ADULTS RECEIVE A BOOSTER VACCINE EVERY TEN YEARS, AND STANDARD CARE PRACTICE IN MANY PLACES IS TO GIVE THE BOOSTER TO ANY PATIENT WITH A PUNCTURE WOUND WHO IS UNCERTAIN OF WHEN HE OR SHE WAS LAST VACCINATED, OR IF HE OR SHE HAS HAD FEWER THAN THREE LIFETIME DOSES OF THE VACCINE. THE BOOSTER MAY NOT PREVENT A POTENTIALLY FATAL CASE OF TETANUS FROM THE CURRENT WOUND, HOWEVER, AS IT CAN TAKE UP TO TWO WEEKS FOR TETANUS ANTIBODIES TO FORM. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED THE NEEDLE THROUGH THE SHIELD. SINCE THE NEEDLE WAS THROUGH THE SHIELD, EXPOSING THE CANNULA, A NEEDLE STICK COULD OCCUR. HOWEVER, THE NEEDLE THROUGH THE SHIELD ISSUE CANNOT BE CONFIRMED AS A DEFECT AS THIS ISSUE OCCURRED AFTER THE SAMPLE HAD BEEN USED AND RE-SHIELDED. COMPLAINT HISTORY CHECK WAS PERFORMED AND AS OF ((B)(6) 2013) THIS IS THE FIRST COMPLAINT AGAINST LOT NUMBER 2333449 FOR SIMILAR ISSUE. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. PER THE WEBSITE, PATIENT INSERT, "DO NOT RECAP OR CLIP A NEEDLE THAT HAS BEEN USED BY OR ON ANOTHER PERSON. THIS CAN LEAD TO ACCIDENTAL NEEDLESTICKS WHICH MAY CAUSE SERIOUS INFECTIONS."

    Description of Event or Problem · 1

    THE REPORTER STARTED THAT THE CUSTOMER FOUND A SYRINGE WITH THE NEEDLE STICKING OUT OF THE CAP AND SHE PRICKED HERSELF. ADDITIONAL INFORMATION RECEIVED DURING RECEIPT OF THE SAMPLE ON (B)(6) 2013, WHICH STATED THAT THERE WAS A NEEDLE STICK WITH A DIRTY NEEDLE. SPOKE WITH THE CONSUMER VIA TELEPHONE WHO STATED THAT THIS WAS AN INCIDENT WITH HER GIVING HER DOG AN INSULIN INJECTION. AFTER ADMINISTRATION OF THE MEDICATION THE NEEDLE WAS STICKING OUT THROUGH THE CAP AND SHE WAS STUCK. THE CONSUMER STATED THAT SHE HAD TO RECEIVE A TETANUS SHOT DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218014 BD SYRINGE 29G X 1/2ML SYRINGE FMF BD 2333449

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention