BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 20GA 1IN

    MDR report key: 10687999 · Received October 15, 2020

    Report

    Report Number
    1911916-2020-00960
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 1, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051756
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 8324804. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 20GA 1IN LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHEN THE NURSE PULLED THE PLUNGER BACK ON THE 3ML SYRINGE THE MEDICATION SPILLED OUT SURROUNDING THE NEEDLE/SYRINGE CONNECTION POINT. PER ATTACHED FOLLOW UP RESPONSE: FOR 1835952. INCIDENT DATE? (B)(6) 2020 AND (B)(6) 2020. WHAT MEDICATION WAS BEING DRAWN UP? ON (B)(6)- PEVNAR23 AND ON (B)(6)- PREVNAR13. IS PRODUCT AVAILABLE TO RETURN FOR INVESTIGATION? THIS SPECIFIC PRODUCT WAS THROWN AWAY BUT HAVE UNUSED PRODUCTS THAT CAN BE SENT. EVENT DESCRIPTION STATES: THERE HAD BEEN A FEW INSTANCES WHERE ONE OF MY CLINICS HAVE HAD ISSUES WITH A COUPLE BD PRODUCTS WHEN THEY WERE PERFORMING MEDICATION ADMINISTRATION. IN BOTH INSTANCES MEDICATION SPRAYED OUT OF THE NEEDLE/SYRINGE CONNECTION POINT. THE PRODUCTS THAT WERE USED, PRODUCT # AND LOT # ARE BELOW: BD 3ML SYRINGE WITH LUER-LOK TIP PRODUCT # 9870248 LOT # 0122550, BD PRECISION GLIDE NEEDLE 20G X 1¿ PRODUCT # 9872550 LOT # 8324804. PLEASE SEE THE 3 FORMS FOR MORE INFORMATION. ANY INFORMATION REGARDING WHETHER THIS IS A PRODUCT ISSUE OR USER ERROR WOULD BE APPRECIATED. EVENT DETAILS STATES: IN SEPARATE INSTANCES, MY NURSING TEAM HAS HAD ISSUES WITH THE BD 3ML SYRINGE WHEN THEY WERE DRAWING UP OR ADMINISTERING MEDICATIONS. THE FIRST INSTANCE CAME ABOUT WHEN NURSING STAFF TIGHTENED A BD PRECISIONGLIDE 20G X 1" NEEDLE ONTO A BD 3ML SYRINGE TO DRAW UP MEDICATION TO ADMINISTER TO A PATIENT. WHEN THE NURSE PULLED THE PLUNGER BACK ON THE 3ML SYRINGE THE MEDICATION SPILLED OUT SURROUNDING THE NEEDLE/SYRINGE CONNECTION POINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152625 NEEDLE 20GA 1IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305175 8324804 30382903051756

    Patients

    Seq Age Sex Outcome Treatment
    1 Other