BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1 RB

    MDR report key: 19011038 · Received April 1, 2024

    Report

    Report Number
    1911916-2024-00226
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 17, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WERE DOTS ON THE NEEDLE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A SEALED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 10X MAGNIFICATION. THE PLASTIC SHIELD HAS BLACK SPECKS OF EMBEDDED DEGRADED RESIN. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. 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 305195, LOT 3233736. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL#: 305195, BATCH NUMBER#: 3233736. IT WAS REPORTED BY CUSTOMER THAT FOUND A 18G BD NEEDLE WITH ODD DOTS ALL ACROSS THE SURFACE. THE DOTS ARE NOT A PART OF THE THIN PLASTIC PACKAGING, BUT RATHER ON THE NEEDLE ITSELF. IT MAY POSSIBLY BE INK OR SOME OTHER RESIDUE, BUT IT DID NOT SEEM SAFE OR STERILE TO USE. IN CONJUNCTION WITH THE 18G BD NEEDLE WITH A PIECE OF HAIR IMBEDDED INTO THE PACKAGING WAS ALSO FOUND A FEW WEEKS AGO, IT DOES RAISE QUESTIONS ABOUT THE CURRENT MANUFACTURING PRACTICES WITH THESE NEEDLES. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. OVER THE WEEKEND IV ROOM PHARMACY TECH FOUND A 18G BD NEEDLE WITH ODD DOTS ALL ACROSS THE SURFACE. THE DOTS ARE NOT A PART OF THE THIN PLASTIC PACKAGING, BUT RATHER ON THE NEEDLE ITSELF. IT MAY POSSIBLY BE INK OR SOME OTHER RESIDUE, BUT IT DID NOT SEEM SAFE OR STERILE TO USE. IN CONJUNCTION WITH THE 18G BD NEEDLE WITH A PIECE OF HAIR IMBEDDED INTO THE PACKAGING WAS ALSO FOUND A FEW WEEKS AGO, IT DOES RAISE QUESTIONS ABOUT THE CURRENT MANUFACTURING PRACTICES WITH THESE NEEDLES. I HAVE A SAMPLE OF THE PRODUCT IN MY OFFICE. LOT NUMBER IS 3233736. RESPONSE: UNFORTUNATELY, THE NEEDLE WITH THE HAIR WAS NOT SAVED AND THE LOT NUMBER WAS NOT NOTED. ISSUE OCCURRED ON 3/18. PRODUCT WAS SAVED.

    Description of Event or Problem · 0

    MATERIAL#: 305195. BATCH NUMBER#: 3233736. IT WAS REPORTED BY CUSTOMER THAT FOUND A 18G BD NEEDLE WITH ODD DOTS ALL ACROSS THE SURFACE. THE DOTS ARE NOT A PART OF THE THIN PLASTIC PACKAGING, BUT RATHER ON THE NEEDLE ITSELF. IT MAY POSSIBLY BE INK OR SOME OTHER RESIDUE, BUT IT DID NOT SEEM SAFE OR STERILE TO USE. IN CONJUNCTION WITH THE 18G BD NEEDLE WITH A PIECE OF HAIR IMBEDDED INTO THE PACKAGING WAS ALSO FOUND A FEW WEEKS AGO, IT DOES RAISE QUESTIONS ABOUT THE CURRENT MANUFACTURING PRACTICES WITH THESE NEEDLES. UNFORTUNATELY, THE NEEDLE WITH THE HAIR WAS NOT SAVED AND THE LOT NUMBER WAS NOT NOTED. ISSUE OCCURRED ON (B)(6). PRODUCT WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566240 NEEDLE 18X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3233736 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown