BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19997139 · Received August 15, 2024

    Report

    Report Number
    1213809-2024-00551
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 24, 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

    (B)(4) FOLLOW UP REPORT FOR CORRECTION. THIS COMPLAINT WAS FOUND TO BE A DUPLICATE AFTER THE MDR WAS SUBMITTED, PLEASE REFER TO (B)(4).

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    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: VERBATIM: 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. REF REPORT: MW5157322.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362774 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4033669 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown