BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE NEEDLE

    MDR report key: 11558317 · Received March 23, 2021

    Report

    Report Number
    1213809-2021-00156
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Date of Event
    February 25, 2021
    Report Date
    March 26, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059059
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND ONE LOOSE 3ML SYRINGE WITH SAFETYGLIDE NEEDLE ASSEMBLY ATTACHED WERE RECEIVED AND EVALUATED. THE PLUNGER ROD WAS PULLED BACK AND THE STOPPER ALMOST INSTANTLY BECAME DISCONNECTED. IT WAS OBSERVED THE RETAINING RING ON THE PLUNGER ROD WAS NOT COMPLETELY FORMED, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER SEPARATION DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPER SEPARATED FROM THE BD SAFETYGLIDE¿ NEEDLE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER SEPARATE WITH PUTTER".

    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. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980987 (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPER SEPARATED FROM THE BD SAFETYGLIDE¿ NEEDLE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER SEPARATE WITH PUTTER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454500 BD SAFETYGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305905 9304558 30382903059059

    Patients

    Seq Age Sex Outcome Treatment
    1