BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW

    MDR report key: 20232786 · Received September 16, 2024

    Report

    Report Number
    1213809-2024-00631
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    July 3, 2024
    Report Date
    November 7, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903043874
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)- SUPPLEMENTAL MDR -NEEDLE PULLED OUT OF HUB 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.

    Additional Manufacturer Narrative · 0

    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 # 304387. BATCH # 3040029. IT WAS REPORTED THAT THE BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE CUSTOMER ADVISED THAT THE PATIENT WAS BEING ADMINISTERED EUFLEXXA, THE PA ADMINISTERED THE INJECTION AND AS THE NEEDLE WAS BEING REMOVED FROM THE PATIENTS KNEE, THE NEEDLE BROKE OFF OF THE HUB. THE NEEDLE WAS ALMOST OUT AND THE PA WAS ABLE TO SAFELY REMOVE THE NEEDLE WITH NO INJURY TO THE PATIENT. PART NUMBER: 304387. LOT#: 3040029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1901398 BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 3040029 30382903043874

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown