BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 9033773 · Received September 13, 2019

    Report

    Report Number
    1213809-2019-00924
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 29, 2019
    Report Date
    October 7, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059035
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ INSULIN SYRINGE'S ATTACHED NEEDLE WAS FOUND DEFORMED BEFORE USE AFTER REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I OPENED A LIDO NEEDLE AND WHEN I TOOK IT OUT OF ITS PACKAGE THIS IS WHAT IT LOOKED LIKE. I'VE INCLUDED THE LOT INFO JUST INCASE THERE ARE OTHER MESSED UP NEEDLES."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: PISTON SYRINGE. MEDICAL DEVICE TYPE: FMF. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980580 (SYRINGE). PMA / 510(K)#: K951254 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ INSULIN SYRINGE'S ATTACHED NEEDLE WAS FOUND DEFORMED BEFORE USE AFTER REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I OPENED A LIDO NEEDLE AND WHEN I TOOK IT OUT OF ITS PACKAGE THIS IS WHAT IT LOOKED LIKE. IVE INCLUDED THE LOT INFO JUST INCASE THERE ARE OTHER MESSED UP NEEDLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826625 BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other