BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO

    MDR report key: 19824704 · Received July 25, 2024

    Report

    Report Number
    1911916-2024-00534
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 10, 2024
    Report Date
    September 12, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    50382903020473
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED ONE BAG WAS MISSING A LABEL, AN INNER BAG WAS DISCOVERED UNSEALED, AND NEEDLES HAD RESIDUALS OF EPOXY ON HUB. TO AID IN THE INVESTIGATION, TWELVE SAMPLES WITH NO PACKAGING AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHYSICAL SAMPLES HAVE AN EPOXY DRIP OVER ON THE NEEDLE HUB. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EXCESSIVE EPOXY COULD OCCUR DURING THE ASSEMBLY PROCESS IF THERE WAS A MISFEEDING OF THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302047, LOT 3271798. 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 SAMPLES 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 OF EPOXY EXCESSIVE REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    10-JUN-2024, NEEDLES CAT 9080101/21915233, LOT 3271798/ RA00002494 WERE RECEIVED. DURING THE VISUAL VERIFICATION CHECK, IT WAS DISCOVERED THAT: - 1 BAG OF 25,000 UNITS WAS DISCOVERED WITHOUT IDENTIFICATION LABEL - ANOTHER BAG WITH OPEN INNER BAG WAS DISCOVERED, UNSEALED. 12 NEEDLES OUT OF 1250 INSPECTED DISCOVERED WITH RESIDUALS OF EPOXY ON HUB (OUT OF SPEC. ACCORDING TO ANSI 10 AC, 11 RE).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED 10-JUN-2024, NEEDLES CAT 9080101/21915233, LOT 3271798/ RA00002494 WERE RECEIVED. DURING THE VISUAL VERIFICATION CHECK, IT WAS DISCOVERED THAT: (B)(4) BAG OF (B)(4) UNITS WAS DISCOVERED WITHOUT IDENTIFICATION LABEL ANOTHER BAG WITH OPEN INNER BAG WAS DISCOVERED, UNSEALED. 12 NEEDLES OUT OF 1250 INSPECTED DISCOVERED WITH RESIDUALS OF EPOXY ON HUB (OUT OF SPEC. ACCORDING TO ANSI 10 AC, 11 RE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482357 NEEDLE NS 30GA 1/2IN BNS YEL HUB TW EURO NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3271798 50382903020473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown