BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 9315689 · Received November 13, 2019

    Report

    Report Number
    1213809-2019-01135
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 2, 2019
    Report Date
    January 10, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059189
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS AND THREE USED SAFETYGLIDE NEEDLES INSIDE OPENED BLISTER PACKAGES WERE RECEIVED. THE PACKAGES WERE CONFIRMED TO BE FROM BATCH #9121600 (P/N 305918). THE PHOTO DEPICTED A SINGLE LOOSE SAFETYGLIDE NEEDLE, SAFETY SHIELD NOT EXTENDED, IN A PERSON¿S HAND WITH A FINGER POINTING AT THE HUB. NO LIQUID DROPLETS WERE SEEN IN THE PHOTO. IT WAS NOT CLEAR IF THERE WAS ANY LEAKAGE RESIDUE NEAR THE EDGE OF THE HUB. ONE (1) SAMPLE WAS RETURNED FOR INVESTIGATION. THE SAMPLE WAS CONNECTED TO A SYRINGE FILLED WITH WATER AND THE WATER WAS EXPELLED THROUGH THE SYRINGE DURING WHICH IT WAS NOTED THAT WATER LEAKED FROM THE NEEDLE / HUB CONNECTION. THE SAFETY SHIELD WAS THEN REMOVED AND THE NEEDLE HUB ASSEMBLY WAS EXAMINED USING 10X MAGNIFICATION. IT WAS OBSERVED THAT THERE WAS INSUFFICIENT EPOXY ON THE NEEDLE AS EPOXY WAS ONLY PRESENT ON ONE (1) SIDE OF THE NEEDLE. THIS ALLOWED A GAP BETWEEN THE NEEDLE AND NEEDLE HUB WHICH LEAKED DURING USE. POSSIBLE ROOT CAUSE, A MACHINE MALFUNCTION CAUSED INSUFFICIENT EPOXY TO BE APPLIED TO THE NEEDLE HUB / CANNULA ASSEMBLY WHICH RESULTED IN EPOXY BEING APPLIED TO ONLY ONE (1) SIDE OF THE NEEDLE. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305918; BATCH NO.: 9121600. IT WAS REPORTED LEAKING OF NEEDLE. PR 1 OF 3: THIS PR IS FOR DATE OF EVENT ON (B)(6) 2019. OCCURRED DURING MEDICATION PREPARATION IN PHARMACY. NO NEEDLE STICK.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305918 BATCH NO.: 9121600. IT WAS REPORTED LEAKING OF NEEDLE. THIS PR IS FOR DATE OF EVENT (B)(6) 2019 OCCURRED DURING MEDICATION PREPARATION IN PHARMACY. NO NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108167 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 9121600 30382903059189

    Patients

    Seq Age Sex Outcome Treatment
    1 Other