BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 27X5/8 RB

    MDR report key: 10209906 · Received June 29, 2020

    Report

    Report Number
    1213809-2020-00426
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    June 7, 2020
    Report Date
    August 7, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059219
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10. DEVICE AVAILABLE FOR EVAL?: YES. D10. RETURNED TO MANUFACTURER ON: 7/7/2020. H6. INVESTIGATION: TWO PHOTOS AND TWO SAFETYGLIDE NEEDLE ASSEMBLIES WERE RECEIVED AND EVALUATED. ONE WAS IN A FULLY SEALED BLISTER PACK FROM BATCH 0002401 (P/N 305921) AND ONE WAS LOOSE INSIDE A PLASTIC CONTAINER. IT WAS OBSERVED THROUGH THE CONTAINER, THE LOOSE NEEDLE ASSEMBLY WAS MISSING THE BOTTOM HALF OF THE SAFETY SHIELD, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING SAFETY SHIELD DEFECT IS ASSOCIATED WITH THE NEEDLE MANUFACTURING PROCESS. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE EPOXY TO FIX IT; AFTER THAT, A PLASTIC SAFETY MECHANISM IS ASSEMBLED, AT THE END THE PLASTIC SHIELD IS ASSEMBLED TO THE PART. IN THIS CASE, THE SAFETY MECHANISM WAS NOT PROPERLY ASSEMBLED. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0002401 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE SFTYGLD 27X5/8 RB SAFETY MECHANISM WAS BROKEN. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305921 BATCH NO: 0002401. IT WAS REPORTED THAT: RN REMOVED SYRINGE FROM PACKAGE, REVEALED NO SAFETY SHIELD ON/FOR NEEDLE. EVENT DESCRIPTION PER EMAIL STATES: RN ADMINISTERED SUBCUTANEOUS INJECTION AT PATIENT BEDSIDE. RN WENT TO DO ACTIVATE THE SAFETY NEEDLE DEVICE AND WAS UNABLE TO DO SO AS PART OF THE SAFETY DEVICE WAS MISSING/BROKEN. RN SEARCHED PATIENTS BEDDING AND FLOOR FOR MISSING PIECE. RN DID NOT HEAR/FEEL ANYTHING BREAK OR FALL TO FLOOR. RN STATED "I THINK IT'S JUST MISSING A PIECE". RN ALSO STATED SHE "GAVE THE INJECTION BEFORE I NOTICED A PIECE WAS MISSING." SAFETY CLOSURE DEVICE BROKEN AND UNABLE TO ACTIVATE THE SAFETY MECHANISM.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE SFTYGLD 27X5/8 RB SAFETY MECHANISM WAS BROKEN. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305921 BATCH NO: 0002401. IT WAS REPORTED THAT: RN REMOVED SYRINGE FROM PACKAGE, REVEALED NO SAFETY SHIELD ON/FOR NEEDLE. EVENT DESCRIPTION PER EMAIL STATES: RN ADMINISTERED SUBCUTANEOUS INJECTION AT PATIENT BEDSIDE. RN WENT TO ACTIVATE THE SAFETY NEEDLE DEVICE AND WAS UNABLE TO DO SO AS PART OF THE SAFETY DEVICE WAS MISSING/BROKEN. RN SEARCHED PATIENTS BEDDING AND FLOOR FOR MISSING PIECE. RN DID NOT HEAR/FEEL ANYTHING BREAK OR FALL TO FLOOR. RN STATED "I THINK IT'S JUST MISSING A PIECE." RN ALSO STATED SHE "GAVE THE INJECTION BEFORE I NOTICED A PIECE WAS MISSING." SAFETY CLOSURE DEVICE BROKEN AND UNABLE TO ACTIVATE THE SAFETY MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674251 NEEDLE SFTYGLD 27X5/8 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305921 0002401 30382903059219

    Patients

    Seq Age Sex Outcome Treatment
    1 Other