BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9546551 · Received January 3, 2020

    Report

    Report Number
    1911916-2019-01364
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 10, 2019
    Report Date
    January 10, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS PROVIDED. IT SHOWS A NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD. THE TOP PART OF THE NEEDLE WENT THROUGH THE PLASTIC SHIELD. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR. THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE EPOXY TO FIX IT AFTER THAT A PLASTIC HUB IS ASSEMBLED. IN THIS CASE THE NEEDLE EITHER WAS BENT OR NOT PROPERLY PLACED INDUCING THAT THE NEEDLE WENT THROUGH THE PLASTIC SHIELD AND NOT DETECTED IN THE NEXT PROCESSES. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO: 303010 BATCH NO: 9121702. IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE WAS STICKING THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THE NEEDLE PORTION WAS STICKING THROUGH ITEM 500596 NDL, 25G X 5/8" REG BEV BLU HB.

    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: 303010 BATCH NO: 9121702. IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THE NEEDLE WAS STICKING THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THE NEEDLE PORTION WAS STICKING THROUGH ITEM 500596 NDL, 25G X 5/8" REG BEV BLU HB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12117 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9121702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other