BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE NEEDLE

    MDR report key: 10492013 · Received September 3, 2020

    Report

    Report Number
    1213809-2020-00599
    Event Type
    Malfunction
    Date Received
    September 3, 2020
    Date of Event
    August 6, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR HAS BEEN IDENTIFIED AS A COMPLAINT OF MFR REPORT #: 1213809-2020-00573. THIS INCIDENT HAS ALREADY BEEN CAPTURED THEREFORE THIS COMPLAINT CAN BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD SAFETYGLIDE¿ NEEDLES EXPERIENCED CLOGGED/BLOCKED NEEDLES AND DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305916 BATCH NO: 305916 I HAVE RAN INTO THE 25G X 1 BD SAFETY GLIDE NEEDLE LOT #9232455 STICKING IN PLACE. WHEN I GO TO GIVE A SHOT IT INJECTS UP TO ½ MARK AND THEN STOPS. IT WILL NOT MOVE AT ALL. I THEN TAKE IT OUT OF THE PT AND TRY PUSHING THE PLUNGER AND IT STILL WONT WORK. THIS HAS HAPPENED TWICE NOW. I TAKE OFF THE ORIGINAL NEEDLE AFTER DRAWING UP THE MEDICATION. IT HAS NEVER MALFUNCTIONED WHEN GIVING VACCINATIONS. IT HAS MALFUNCTIONED TWICE WHEN GIVING KENALOG WHICH IS A THICKER MEDICATION. IT HAS WORKED MULTIPLE TIMES WITH THE SAME MEDICATION. I DON'T KNOW IF IT'S THE NEEDLE OR THE SYRINGE. IM PRETTY SURE IT'S THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD SAFETYGLIDE¿ NEEDLES EXPERIENCED CLOGGED/BLOCKED NEEDLES AND DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305916, BATCH NO: 305916. I HAVE RAN INTO THE 25G X 1 BD SAFETY GLIDE NEEDLE LOT #9232455 STICKING IN PLACE. WHEN I GO TO GIVE A SHOT IT INJECTS UP TO ½ MARK AND THEN STOPS. IT WILL NOT MOVE AT ALL. I THEN TAKE IT OUT OF THE PT AND TRY PUSHING THE PLUNGER AND IT STILL WONT WORK. THIS HAS HAPPENED TWICE NOW. I TAKE OFF THE ORIGINAL NEEDLE AFTER DRAWING UP THE MEDICATION. IT HAS NEVER MALFUNCTIONED WHEN GIVING VACCINATIONS. IT HAS MALFUNCTIONED TWICE WHEN GIVING KENALOG WHICH IS A THICKER MEDICATION. IT HAS WORKED MULTIPLE TIMES WITH THE SAME MEDICATION. I DON'T KNOW IF IT'S THE NEEDLE OR THE SYRINGE. IM PRETTY SURE IT'S THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951179 BD SAFETYGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 9232455 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other