BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9266429 · Received November 1, 2019

    Report

    Report Number
    1911916-2019-01148
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Date of Event
    October 2, 2019
    Report Date
    November 7, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051220
    PMA / PMN Number
    K021475
    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: ONE (1) PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTO SHOWS TWO (2) BLISTER PACKS LYING NEXT TO TWO (2) NEEDLE HUB ASSEMBLIES. THE NEEDLE ASSEMBLY ON THE RIGHT HAS A NEEDLE THAT APPEARS TO BE LONGER THAN THE NEEDLE ASSEMBLY ON THE LEFT; HOWEVER, THE NEEDLE HUBS ARE THE SAME COLOR. IT WAS ALSO NOTED THAT THE PRINTING ON THE TOP WEB OF THE TWO (2) BLISTER PACKS APPEARS TO BE DIFFERENT AS WELL. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. BASED ON THE INVESTIGATION CONCLUSION BD ACKNOWLEDGES THAT THE PHOTO PROVIDED BY CUSTOMER HAS NEEDLES OF TWO (2) DIFFERENT LENGTHS. AS THE CUSTOMER REPORTED ONE (1) OCCURRENCES OF A SHORTER NEEDLE BEING FOUND IT IS LIKELY THAT A SHORTER LENGTH NEEDLE BECAME LODGED IN A CANNULA CARTRIDGE AND THEN THE CARTRIDGE WAS REFILLED WITH LONGER NEEDLES AT WHICH TIME THE SHORTER LENGTH NEEDLE BECAME DISLODGED AND WAS ASSEMBLED. A TRUE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO: 30512,2 BATCH NO: 9093865. IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE INSIDE THE PACKAGING IS SMALLER THAN THE NEEDLE USUALLY RECEIVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ORDERED 1 BOX OF BD305122 FROM ORDERS (B)(4). WHEN SHE OPENED THE INDIVIDUAL NEEDLE PACKAGING, SHE NOTICED IT IS MUCH SMALLER. CUSTOMER SAYS THAT THIS IS BD PACKAGING ERROR WHERE THE PACKAGING IS INCORRECT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO: 305122, BATCH NO: 9093865. IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE INSIDE THE PACKAGING IS SMALLER THAN THE NEEDLE USUALLY RECEIVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER ORDERED 1 BOX OF BD305122 FROM ORDERS (B)(4). WHEN SHE OPENED THE INDIVIDUAL NEEDLE PACKAGING, SHE NOTICED IT IS MUCH SMALLER. CUSTOMER SAYS THAT THIS IS BD PACKAGING ERROR WHERE THE PACKAGING IS INCORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059173 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9093865 30382903051220

    Patients

    Seq Age Sex Outcome Treatment
    1 Other