BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7000305 · Received November 3, 2017

    Report

    Report Number
    1213809-2017-00230
    Event Type
    Malfunction
    Date Received
    November 3, 2017
    Date of Event
    October 9, 2017
    Report Date
    December 20, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: LOT # 6001842; DEVICE EXPIRATION DATE: 12/31/2020; DEVICE MANUFACTURING DATE: 1/1/2016. BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR INCORRECTLY LABELED WITH THE INCIDENT LOT WAS OBSERVED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. BD HAS INITIATED A CAPA (B)(4) TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE(S) OF THIS PRODUCT ISSUE.

    Additional Manufacturer Narrative · 1

    NO LOT # PROVIDED. 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 LABEL ON A 25 G X 1 IN. BD SAFETYGLIDE" NEEDLE STATES 5/8 BUT EVERYTHING ELSE STATES 1. THE LABELING ERROR WAS NOTICED BEFORE USE AND THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779001 25 G X 1 IN. BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other