BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ PEN NEEDLE

    MDR report key: 7879053 · Received September 14, 2018

    Report

    Report Number
    9616657-2018-00042
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    August 25, 2018
    Report Date
    October 26, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED A CANISTER CONTAINING (2) BLISTER PACKS FOR BD SAFETYGLIDE SYRINGES FROM LOT # 8031730 WHICH ARE NOT BD DIABETES CARE PRODUCTS. THESE WERE RECEIVED IN FLKS COMPLAINT HANDLING LAB ON (B)(6) 2018. THE SAMPLES REPORTED IN THIS COMPLAINT AND IN QUESTION WERE NOT RETURNED BY THE CUSTOMER. NO SAMPLES (INCLUDING PHOTOS) OF THE PRODUCTS IN QUESTION WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW FOR LOT 8037904, CAT NO. (B)(4) WAS CARRIED OUT AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THE PACKAGED LOT OR THE SUB-ASSEMBLY FOR LEAKAGES CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES/PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ PEN NEEDLES ARE LEAKING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE PEN NEEDLES ARE LEAKING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720368 BD ULTRA-FINE¿ PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8037904

    Patients

    Seq Age Sex Outcome Treatment
    1 Other