BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8370357 · Received February 26, 2019

    Report

    Report Number
    1213809-2019-00279
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Date of Event
    February 8, 2019
    Report Date
    July 8, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059028
    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

    INVESTIGATION: ONE PIECE OF TOP WEB, TWO SAMPLES AND TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE SAMPLE WAS A SEALED SAFETYGLIDE NEEDLE, CONFIRMED TO BE FROM BATCH #8143734 (P/N 305902). ONE SAMPLE WAS A 3ML SYRINGE WITH A SAFETYGLIDE NEEDLE ATTACHED ALONGSIDE AN OPENED PACKAGE FROM THE SAME BATCH # AND A TOP WEB FROM UNIDENTIFIED BATCH #. THE OPEN SAMPLE WAS FOUND TO HAVE WHITE FIBROUS FOREIGN MATTER ON THE NEEDLE¿S CANNULA UNDER THE SHIELD. THE SHIELD OF THIS SAMPLE WAS ALSO OBSERVED TO BE CRACKED. IT WAS NOT CLEAR WHETHER THE SHIELD¿S DAMAGE OCCURRED DURING THE SAMPLE¿S TRANSPORT TO THE SITE FOR EVALUATION OR IT WAS CRACKED AT ANOTHER POINT PRIOR TO THAT. TWO (2) RETURNED SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. ONE (1) SAMPLE WAS RETURNED ATTACHED TO A SYRINGE AND THE OTHER SAMPLE WAS RETURNED IN A SEALED BLISTER PACK. BOTH SAMPLES WERE EXAMINED VISUALLY USING 10X MAGNIFICATION. THE RETURNED SAMPLE WHICH WAS ATTACHED TO THE SYRINGE WAS FOUND TO HAVE PLASTIC SHAVINGS (SKIVING) ON THE NEEDLE. IT WAS ALSO OBSERVED THAT THE NEEDLE SHIELD WAS DAMAGED. THE RETURNED SAMPLE WHICH WAS RETURNED IN A SEALED BLISTER PACK WAS FOUND TO NOT HAVE ANY DAMAGE, THE BEVELS WERE GOOD AND THE ETCH WAS GOOD WITH NO DEFECTIVE GRIND OR HOOK OBSERVED DURING PRODUCTION OF THIS BATCH AN ISSUE WAS IDENTIFIED AND ADDITIONAL MEASURES WERE TAKEN TO ASSURE RELEASE OF THE PRODUCT. ADDITIONAL SAMPLING WERE TESTED AND PASSED ; THEREFORE, THE PRODUCT WAS ACCEPTED AND RELEASED. BASED ON THE SAMPLE ANALYSIS IT APPEARS THAT THE PLASTIC SHAVING (SKIVING) ON THE NEEDLE WERE LIKELY THE RESULT OF A NEEDLE WITH SKIVING CAUSED BY POINT DAMAGE. BASED ON THE SAMPLE ANALYSIS THE CONDITION OF NEEDLE DULL / BLUNT COULD NOT BE CONFIRMED AS THE RETURNED SAMPLE WHICH WAS RETURNED IN A SEALED BLISTER PACK WAS FOUND TO NOT HAVE ANY DAMAGE, THE BEVELS WERE GOOD AND THE ETCH WAS GOOD WITH NO DEFECTIVE GRIND OR HOOK OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ NEEDLE HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 HAD FOREIGN MATTER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164464 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 8143734 30382903059028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other