BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X5/8 RB

    MDR report key: 10168858 · Received June 18, 2020

    Report

    Report Number
    1213809-2020-00395
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 27, 2020
    Report Date
    July 1, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059011
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SHIELDED SAFETYGLIDE NEEDLE IN AN OPENED PACKAGE WAS RECEIVED, CONFIRMED TO BE FROM BATCH #0023064 (P/N 305901). THE SAMPLE WAS VISUALLY EVALUATED. THE NEEDLE WAS CONFIRMED TO BE 25X5/8 ¿ CORRECT SIZE FOR THIS PRODUCT. HOWEVER, IT HAD FRONT PART OF ITS SAFETY SHIELD MISSING FROM THE HINGE UP ¿ THE PART THAT SLIDES OVER THE CANNULA TO COVER THE TIP AFTER USE. HAVING THIS PART MISSING, EXPOSED CANNULA CLOSER TO THE HUB MAKING THE APPEARANCE OF A LONGER CANNULA. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 0023064 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A POTENTIAL ROOT CAUSE FOR THE BROKEN SAFETY SHIELD DEFECT IS ASSOCIATED WITH THE NEEDLE MANUFACTURING PROCESS AT BD COLUMBUS. AFTER EVALUATION FROM BD COLUMBUS, IT WAS DETERMINED A ROOT CAUSE WAS RELATED TO THE MULTIVAC PACKAGING PROCESS. THE DEFECT MAY HAVE OCCURRED WHEN THE INCORRECT NEEDLE ASSEMBLY WAS NOT REMOVED DURING A LINE CLEARANCE. AS A RESULT, THE DEFECT WAS VERIFIED. CAPA 790699 WAS CREATED AT BD COLUMBUS TO MONITORING COMPLAINTS FOR THIS COMPONENT PRODUCT AND LOT INVOLVED. NO CORRECTIVE ACTIONS ARE WARRANTED AT THE BD CANAAN BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0023064 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A "30 MM" NEEDLE WAS FOUND MIXED INTO THE PACK OF NEEDLES SFTYGLD 25X5/8 RB BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD NEEDLES LOT #0023064 EXPIR. 1-31-2025. IT LOOKS LIKE BD HAS A 30MM NEEDLE IN SOME OF THE 25G X 5/8" PACKAGING. MY CLIENT STATES THAT THE PACKAGES ARE SEALED AND STATE THAT THEY ARE THE CORRECT 25G X 5/8" SAFETY NEEDLES, BUT THEY FOUND ONE THAT HAD A MUCH LARGER 30MM NEEDLE IN THE SEALED PACK."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "30 MM" NEEDLE WAS FOUND MIXED INTO THE PACK OF NEEDLES SFTYGLD 25X5/8 RB BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD NEEDLES LOT #0023064 EXPIR. 1-31-2025. IT LOOKS LIKE BD HAS A 30MM NEEDLE IN SOME OF THE 25G X 5/8" PACKAGING. MY CLIENT STATES THAT THE PACKAGES ARE SEALED AND STATE THAT THEY ARE THE CORRECT 25G X 5/8" SAFETY NEEDLES, BUT THEY FOUND ONE THAT HAD A MUCH LARGER 30MM NEEDLE IN THE SEALED PACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635908 NEEDLE SFTYGLD 25X5/8 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305901 0023064 30382903059011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other