BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 20049179 · Received August 23, 2024

    Report

    Report Number
    1213809-2024-00576
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 11, 2024
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - NEEDLE CLOGGED/BLOCKED. 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. FURTHERMORE, 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

    MATERIAL #: 305916 BATCH#: 4033669. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DURING A DEPO ADMINISTRATION, THE FULL DOSE OF THE MEDICATION WAS UNABLE TO BE DISPENSED DUE TO BLOCKAGE OF THE NEEDLE. THE NEEDLE WAS REMOVED, AND A 2ND ATTEMPT WAS MADE TO DISPENSE THE MEDICATION WHICH ALSO RESULTED IN PARTIAL ADMINISTRATION OF THE DOSE DUE TO BLOCKAGE. A THIRD ATTEMPT WAS MADE WHICH WAS SUCCESSFUL, HOWEVER, THE PATIENT HAD TO BE STUCK 3 TIMES. LOT #: 4033669

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364304 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4033669 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown