BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLERGY SYRINGE WITH BD PRECISIONGLIDE PERMANENTLY ATTACHED NEEDLE

    MDR report key: 9718047 · Received February 17, 2020

    Report

    Report Number
    1920898-2020-00139
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    February 3, 2020
    Report Date
    February 4, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903055006
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #8120639. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ALLERGY SYRINGE WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE WAS FOUND UNSHEATHED IN THE SEALED PACKAGING BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST REPORTED THAT THE NEEDLE OF ONE SYRINGE WAS UNSHIELDED INSIDE OF THE SEALED BAG. THE NEEDLE CAME THROUGH THE BAG AND STUCK THE TECH ON THE FINGER WHILE HANDLING THE BAG. THE TECH WAS PREPARING TO SELL THE SYRINGES TO A CONSUMER. NO MEDICAL ATTENTION NEEDED, NO INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181927 ALLERGY SYRINGE WITH BD PRECISIONGLIDE PERMANENTLY ATTACHED NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 305500 8120639 30382903055006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other