BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II (SHORT) SELF-CONTAINED INSULIN SYRINGE

    MDR report key: 9203354 · Received October 17, 2019

    Report

    Report Number
    1920898-2019-01161
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    October 2, 2019
    Report Date
    October 18, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED PHOTOS OF A POLY BAG OF 1CC BD SYRINGES FROM LOT#: 9063819. CUSTOMER STATES THAT THERE WAS A NEEDLE STICK, THE NEEDLE WAS UNCAPPED, AND THE NEEDLE WAS BENT. THE ATTACHED PHOTOS WERE EXAMINED AND THE PHOTOS EXHIBITED A SYRINGE WITH THE SHIELD OFF, EXPOSING THE CANNULA, WHICH COULD CAUSE A NEEDLE STICK. HOWEVER, NO BENT CANNULA WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 9063819. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200810808, 200810221] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SHIELD OFF IN THE BAG). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT CANNULA). THE AUTOPACKOUT SYSTEM RECEIVES BAGS OF SYRINGES FROM THE FF&S MACHINE. THE EQUIPMENT ERECTS THE CARTON AND LOADS THE APPROPRIATE AMOUNT OF BAGS OF SYRINGES INTO THE CARTON. THE CARTONS ARE CLOSED BEFORE BEING PLACED ON THE OUTFEED CONVEYOR. UNABLE TO DETERMINE ROOT CAUSE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE CAP WAS LOOSE IN THE SEALED PACKAGE, RESULTING IN A CLEAN NEEDLE STICK BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 NEEDLE WAS UNCAPPED IN THE SEALED PACKAGE- CLIENT HAD NOT OPENED PACKAGE YET. THERE WAS ALSO A NEEDLE STICK INJURY" " I SPOKE TO THE REGISTERED NURSE INVOLVED AND SHE HAS CONFIRMED THAT THE NEEDLE STICK OCCURRED ON SITE AND WAS WITNESSED. THE PACKAGE WAS COMPLETELY SEALED, 1 NEEDLE HAD NO CAP ATTACHED (THE CAP WAS LOOSE IN THE BAG). ALL OTHER NEEDLES IN THE PACK WERE CAPPED. THE NEEDLE TIP THAT STUCK THE INDUVIAL WAS VISIBLE BENT BUT IT WAS UNCLEAR IF THIS WAS A RESULT OF THE INJURY."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE CAP WAS LOOSE IN THE SEALED PACKAGE, RESULTING IN A CLEAN NEEDLE STICK BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 NEEDLE WAS UNCAPPED IN THE SEALED PACKAGE- CLIENT HAD NOT OPENED PACKAGE YET. THERE WAS ALSO A NEEDLE STICK INJURY." "I SPOKE TO THE REGISTERED NURSE INVOLVED AND SHE HAS CONFIRMED THAT THE NEEDLE STICK OCCURRED ON SITE AND WAS WITNESSED. THE PACKAGE WAS COMPLETELY SEALED, 1 NEEDLE HAD NO CAP ATTACHED (THE CAP WAS LOOSE IN THE BAG). ALL OTHER NEEDLES IN THE PACK WERE CAPPED. THE NEEDLE TIP THAT STUCK THE INGLUVIAL WAS VISIBLE BENT BUT IT WAS UNCLEAR IF THIS WAS A RESULT OF THE INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999949 BD ULTRA-FINE II (SHORT) SELF-CONTAINED INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9063819

    Patients

    Seq Age Sex Outcome Treatment
    1 Other