BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW

    MDR report key: 20294104 · Received September 24, 2024

    Report

    Report Number
    1213809-2024-00655
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    July 3, 2024
    Report Date
    October 3, 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

    PR (B)(4). FOLLOW UP MDR FOR DEVICE EVALUATION. THREE HUNDRED FIFTY SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THREE HUNDRED FORTY-NINE SAMPLES WERE RECEIVED IN SEALED PACKAGING BLISTERS AND ONE SAMPLE RECEIVED WITH NO PACKAGING BLISTER AND PLASTIC SHIELD. ONE HUNDRED TWENTY-FIVE SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED WITH A 30X MAGNIFICATION, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAFETY MECHANISM WAS ACTIVATED WITH NO ISSUES OF LOOSE/BROKEN NEEDLE. THE SAMPLE RECEIVED WITH NO PACKAGING BLISTER HAS NO NEEDLE AND THE NEEDLE HUB HAS NO RESIDUE OF EPOXY. BASED ON THE INVESTIGATION WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS IF THERE WAS A MISFEEDING OF THE CANNULATOR. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3040029. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD.

    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 BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE BROKE OFF AT HUB WHEN REMOVING ITEM#304387. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870634 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