BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7122813 · Received December 15, 2017

    Report

    Report Number
    1213809-2017-00346
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 20, 2017
    Report Date
    February 9, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: SAMPLE EVALUATION: TWO SEALED SHELF CARTONS OF 50 NEEDLES EACH, ONE OPEN SHELF CARTON OF 50 SEALED NEEDLES AND ONE OPEN SHELF CARTON OF 40 SEALED NEEDLES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7082802 (P/N 305916). THE SAMPLES WERE VISUALLY EVALUATED. ALL RETURNED SAMPLES WERE IN SEALED PACKAGES. THIRTY PACKAGES WERE RANDOMLY SELECTED TO PERFORM A NEEDLE EVALUATION. ALL SAMPLES WERE REMOVED FROM PACKAGES AND HAD THEIR NEEDLE SHIELD REMOVED. THE NEEDLE CANNULA WAS CUT AND BEVELED AS USUAL. NO BENDS AND NO OTHER DEFECTS WERE OBSERVED IN THE SAMPLES. DHR REVIEW FOR BATCH 7082802 (P/N 305916): MANUFACTURING DATES: 04/26/2017 ¿ 04/27/2017. BATCH QUANTITY WAS 670,500. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7082802 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION: ¿ UNCONFIRMED: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. N/A, NO DEFECTS WERE CONFIRMED. CAPA IS NOT REQUIRED AS NO DEFECTS WERE CONFIRMED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE FROM A BD SAFETYGLIDE¿ NEEDLE BROKE OFF DURING USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903273 BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7082802 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other