BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8819439 · Received July 23, 2019

    Report

    Report Number
    1213809-2019-00763
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 9, 2019
    Report Date
    August 14, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059011
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE OPENED SHELF CARTON CONTAINING 50 SAFETYGLIDE NEEDLES IN FULLY SEALED BLISTER PACKS, CONFIRMED TO BE FROM BATCH #9001891 (B)(4) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THAT THE SAFETYGLIDE NEEDLES ALL HAD ORANGE HUBS AND ORANGE STRIPED BLISTER PACKS. THE CARTON WAS ALSO MARKED WITH AN ORANGE STRIPE UPON WHICH THE NEEDLE GAUGE AND SIZE WERE WRITTEN. THE ORANGE COLOR INDICATES 25G AS PER ISO SPECIFICATION FOR SAFETY NEEDLES. NO DEFECTS WERE OBSERVED IN THE SAMPLES RECEIVED. THE ACCOMPANYING PRINTOUT OF THE CATALOG FROM THE WEBSITE INDICATED THE HUB COLOR AS ¿BLUE¿ FOR THE 25G PRODUCT 305901. FURTHER INVESTIGATION OF THE ONLINE CATALOG AND THE MANUFACTURING STANDARDS CONFIRMED THAT THE INFORMATION IN THE ONLINE CATALOG FOR PRODUCT 305901 IS INCORRECT, WHILE THE COLOR SCHEME IN THE MANUFACTURED PRODUCT IS CORRECT. ORANGE IS THE CORRECT COLOR FOR 25G SAFETY NEEDLES. THE PACKAGING AND THE NEEDLE HUBS CORRECTLY REFLECT THAT COLOR. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE INCORRECT CATALOG COLOR LISTING FOR PRODUCT 305901 IS LIKELY DUE TO IMPROPER UPDATE OF THE CATALOG. THE ONLINE CATALOG WILL BE UPDATED. EXPECTED DUE DATE: 10/31/2019. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE IT WAS NOTICED THAT THE HUB AND LABELING HAVE ORANGE COLOR, HOWEVER HUB SHOULD BE BLUE WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED IN TO REPORT THE NEEDLES HAVE A ORANGE HUB AND ORANGE LABELING ON BOX, SHE STATED SHE WAS NOT AWARE IT WAS THE INCORRECT COLOR HUB UNTIL SHE NOTICED THE BD PRODUCT CATALOG HAS THE HUB COLOR LISTED AS BLUE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE IT WAS NOTICED THAT THE HUB AND LABELING HAVE ORANGE COLOR, HOWEVER HUB SHOULD BE BLUE WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER CALLED IN TO REPORT THE NEEDLES HAVE A ORANGE HUB AND ORANGE LABELING ON BOX, SHE STATED SHE WAS NOT AWARE IT WAS THE INCORRECT COLOR HUB UNTIL SHE NOTICED THE BD PRODUCT CATALOG HAS THE HUB COLOR LISTED AS BLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609436 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 9001891 30382903059011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other