BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7073535 · Received November 30, 2017

    Report

    Report Number
    1213809-2017-00311
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 7, 2017
    Report Date
    February 1, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059011
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DHR REVIEW FOR BATCH 7121692: MANUFACTURING DATES: 06/10/2017 TO 06/11/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7121692 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BD DID NOT RECEIVE ANY SAMPLES BACK FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. HOWEVER, ONE PHOTOGRAPH WAS RETURNED FOR EVALUATION. THE PHOTO DEPICTED A PIECE OF THE SHELF CARTON WITH THE PRODUCT INFORMATION, SUCH AS THE BATCH NUMBER AND EXPIRATION DATE. THE SAMPLE ITSELF WAS NOT PHOTOGRAPHED OR RETURNED FOR EVALUATION. THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. CONCLUSION: THE SAMPLE ITSELF WAS NOT PHOTOGRAPHED OR RETURNED FOR EVALUATION. THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 A BD SAFETYGLIDE¿ NEEDLE HAD A HOLE IN THE SIDE OF THE NEEDLE ATTACHMENT CAUSING THE MEDICATION TO "SQUIRT" OUT DURING USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852416 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7121692 30382903059011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other