BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7375021 · Received March 27, 2018

    Report

    Report Number
    1213809-2018-00145
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    February 26, 2018
    Report Date
    April 11, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTO EVALUATION: 2 PHOTOS WERE PROVIDED FOR EVALUATION DEPICTING A SAFETYGLIDE NEEDLE REPORTED TO BE FROM BATCH #7150520 (P/N 305916). PHOTOS WERE EVALUATED. A SINGLE PIECE OF APPARENTLY LOOSE UNIDENTIFIED BLACK FOREIGN MATTER CAN BE SEEN ON THE NEEDLE HUB AND NUMEROUS SMALL BLACK FM PARTICLES CAN BE SEEN IN THE NEEDLE SHIELD. IT WAS NOT POSSIBLE TO TELL WHETHER THE PARTICLES ARE LOOSE OR EMBEDDED. THE SIZE OF FM IN THE PHOTOS WAS ALSO NOT POSSIBLE TO IDENTIFY. DHR REVIEW FOR BATCH 7150520 (P/N 305916): MANUFACTURING DATES: 07/23/2017 TO 07/24/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7150520 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: CONFIRMED- PRODUCT DEFECT CONFIRMED BASED ON PHOTO EVALUATION.

    Additional Manufacturer Narrative · 1

    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 ¿BLACK FOREIGN MATTER¿ WAS FOUND IN THE FLUID PATH (HUB) OF A BD SAFETYGLIDE¿ NEEDLE PRIOR TO USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216250 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7150520 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other