BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17262370 · Received July 5, 2023

    Report

    Report Number
    1213809-2023-00690
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 18, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479262598
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2188470; D4. MEDICAL DEVICE EXPIRATION DATE: 30JUN2027; H4. DEVICE MANUFACTURE DATE: 07JUL2022; D4. MEDICAL DEVICE LOT #: 2202913; D4. MEDICAL DEVICE EXPIRATION DATE: 30JUN2027; H4. DEVICE MANUFACTURE DATE: 21JUL2022. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2202913. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH LOT OF NEEDLES USED IN THE MANUFACTURE OF THIS BATCH. DURING THE HISTORY REVIEW, ONE LOT WAS IDENTIFIED AS HAVING SUFFERED FROM CLOGGED NEEDLES DUE TO SILICONE. IT COULD BE POSSIBLE SOME SAMPLES ARE ESCAPES FROM THE INCIDENT THAT OCCURRED WHILE PRODUCTION. DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN IMPLEMENTED. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 30 OF THE BD SAFETYGLIDE¿ NEEDLE ARE CLOGGED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: VERBATIM: ITEM: NEEDLES ARE MALFUNCTIONING, SO FAR HAVE HAD THE ISSUE WITH MULTIPLE NEEDLES FROM A BOX THAT WAS RECENTLY OPENED. - ARE YOU ABLE TO DESCRIBE IN DETAIL ABOUT THE MALFUNCTION NEEDLES? THE NEEDLES ARE CLOGGED. ONCE WE ATTACH THE NEEDLE TO A SYRINGE, WE ARE ABLE TO PULL BACK ON THE PLUNGER ONLY TO HAVE THE PLUNGER BOUNCE BACK. IF WE ARE ABLE TO ADD AIR TO A SYRINGE AND THEN ATTACH THE NEEDLE, WE ARE UNABLE TO ADVANCE THE PLUNGER TO DISPEL THE AIR (OR THE MEDICATION). (BROKEN/DULL/CLOGGED/OTHERS?).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 30 OF THE BD SAFETYGLIDE¿ NEEDLE ARE CLOGGED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: VERBATIM: ITEM: NEEDLES ARE MALFUNCTIONING, SO FAR HAVE HAD THE ISSUE WITH MULTIPLE NEEDLES FROM A BOX THAT WAS RECENTLY OPENED. ARE YOU ABLE TO DESCRIBE IN DETAIL ABOUT THE MALFUNCTION NEEDLES? THE NEEDLES ARE CLOGGED. ONCE WE ATTACH THE NEEDLE TO A SYRINGE, WE ARE ABLE TO PULL BACK ON THE PLUNGER ONLY TO HAVE THE PLUNGER BOUNCE BACK. IF WE ARE ABLE TO ADD AIR TO A SYRINGE AND THEN ATTACH THE NEEDLE, WE ARE UNABLE TO ADVANCE THE PLUNGER TO DISPEL THE AIR (OR THE MEDICATION). (BROKEN/DULL/CLOGGED/OTHERS?)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344457 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 306616 SEE H.10 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown