BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 19326174 · Received May 15, 2024

    Report

    Report Number
    1213809-2024-00291
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    May 9, 2024
    Report Date
    November 8, 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
    NJ, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DURING REVIEW OF THE PROCESS, PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. IT COULD BE POSSIBLE SOME SAMPLES ARE ESCAPES FROM THE INCIDENT THAT OCCURRED DURING PRODUCTION. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN IMPLEMENTED. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL: 305916, BATCH#: 2024138 . IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE BLOCKAGE" VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. PRODUCT COMPLAINT-(B)(6). FACILITY: XXXX #828. ADDRESS: XXXXX. CONTACT: XXX. PHONE: XXXX. EMAIL: XXXX. ISSUE: NEEDLE BLOCKAGE. DOE: (B)(6) 2024. EVENT 1 OCCURENCES 2. REF: (B)(4). LOTS: 2024138. SAMPLES: YES. PT HARM: NO. PT WAS STUCK TWICE, PAIN, AND REFUSED ATTEMPT AT THIRD INJECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671153 BD SAFETYGLIDE SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS 2024138 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown