BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23X1-1/2 RB TW

    MDR report key: 20031584 · Received August 22, 2024

    Report

    Report Number
    1911916-2024-00615
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 9, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051947
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THERE ARE SOME SPECKS ON THE PLASTIC PART. TO AID IN THE INVESTIGATION, EIGHTEEN SAMPLES AND THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OR QUALITY TEAM. FIFTEEN SAMPLES WERE FROM LOT 4031270; ELEVEN SAMPLES IN SEALED PACKAGING BLISTERS AND FOUR SAMPLES IN OPENED PACKAGING BLISTERS. TWO SAMPLES FROM LOT 3347792 CAME IN OPENED PACKAGING BLISTERS, AND ONE SAMPLE CAME WITH NO PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED WITH 10X MAGNIFICATION. THE SAMPLES HAVE DARK COLORED SPECKS IN THE NEEDLE HUB, ABOUT 1/64" IN SIZE, OF EMBEDDED DEGRADED RESIN. THE THREE PHOTOS SHOW SOME OF THE SAMPLES RECEIVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305194, LOTS 3347792 AND 4031270. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL #: 305194 BATCH#: 3347792 ,4031270. IT WAS REPORTED BY CUSTOMER THAT PLEASE REVIEW THE ATTACHED PHOTOS OF SOME NEEDLES BD305194 FROM LOT 3347792 AND LOT 4031270. THESE HAVE SOME SPECKS ON THE PLASTIC PART AND HAVE CAUSED SOME CONCERNS FOR ONE OF OUR PATIENTS. THE SPECKS DON¿T SEEM TO BE ON THE OUTSIDE BUT PART OF THE PLASTIC. SOME OF THE SPECKS ARE LARGER THAN OTHERS AND DIFFERENT PLACES. COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. PLEASE REVIEW THE ATTACHED PHOTOS OF SOME NEEDLES BD305194 FROM LOT 3347792 AND LOT 4031270. THESE HAVE SOME SPECKS ON THE PLASTIC PART AND HAVE CAUSED SOME CONCERNS FOR ONE OF OUR PATIENTS. THE SPECKS DON¿T SEEM TO BE ON THE OUTSIDE BUT PART OF THE PLASTIC. SOME OF THE SPECKS ARE LARGER THAN OTHERS AND DIFFERENT PLACES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL #: 305194 , BATCH#: 3347792 ,4031270. IT WAS REPORTED BY CUSTOMER THAT PLEASE REVIEW THE ATTACHED PHOTOS OF SOME NEEDLES BD305194 FROM LOT 3347792 AND LOT 4031270. THESE HAVE SOME SPECKS ON THE PLASTIC PART AND HAVE CAUSED SOME CONCERNS FOR ONE OF OUR PATIENTS. THE SPECKS DON¿T SEEM TO BE ON THE OUTSIDE BUT PART OF THE PLASTIC. SOME OF THE SPECKS ARE LARGER THAN OTHERS AND DIFFERENT PLACES. PLEASE REVIEW THE ATTACHED PHOTOS OF SOME NEEDLES BD305194 FROM LOT 3347792 AND LOT 4031270. THESE HAVE SOME SPECKS ON THE PLASTIC PART AND HAVE CAUSED SOME CONCERNS FOR ONE OF OUR PATIENTS. THE SPECKS DON¿T SEEM TO BE ON THE OUTSIDE BUT PART OF THE PLASTIC. SOME OF THE SPECKS ARE LARGER THAN OTHERS AND DIFFERENT PLACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939949 NEEDLE 23X1-1/2 RB TW NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4031270 30382903051947

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown