BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7073484 · Received November 30, 2017

    Report

    Report Number
    1213809-2017-00309
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 7, 2017
    Report Date
    February 2, 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW FOR BATCH 7121702 (P/N 305916): MANUFACTURING DATES: 06/19/2017 ¿ 6/20/2017. BATCH QUANTITY WAS 670,500. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7121702 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE OPEN SAFETY GLIDE PACKAGED NEEDLE WAS RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH # 7121702 (P/N 305916). THE NEEDLE SHIELD WAS REMOVED FOR THE EVALUATION. THE NEEDLE WAS FOUND TO HAVE MULTIPLE BLACK SPECKS OF EMBEDDED FOREIGN MATTER. THE FM WAS LEVEL 2 IN SIZE AND LOCATED IN THE PLASTIC HINGE. EMBEDDED FOREIGN MATTER THE SIZE OBSERVED IN THIS SAMPLE IS CONSIDERED TO BE A COSMETIC DEFECT. CONCLUSION: BASED ON THE INVESTIGATION, BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE, HOWEVER, THE DEFECT IS COSMETIC AND AN ACCEPTABLE CONDITION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE FACT THAT NO REJECTABLE DEFECT WAS FOUND, CAPA IS NOT REQUIRED AT THIS TIME.

    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 FOREIGN MATTER WAS FOUND EMBEDDED IN A BD SAFETYGLIDE¿ NEEDLE. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852413 BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7121702 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other