BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 8839240 · Received July 29, 2019

    Report

    Report Number
    1213809-2019-00782
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    July 12, 2019
    Report Date
    September 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059028
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED A BLISTER PACK WITH A RIP IN THE TOP WEB FROM BATCH 9093584 (P/N 305902). ONE PHOTO SHOWED AN UNKNOWN SYRINGE WITH A SAFETYGLIDE NEEDLE ATTACHED. DUE TO POOR PICTURE QUALITY IT IS UNCLEAR FROM IF THE TOP HALF OF THE SHIELD WAS BROKEN OFF OR IF THE INCORRECT SHIELD WAS USED TO CAP THE NEEDLE. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES/PHOTOS RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    MATERIAL NO. 305902 BATCH NO. 9093584 IT WAS REPORTED THAT DURING USE OF THE BD SAFETYGLIDE¿ NEEDLE THE NEEDLE WENT THROUGH THE CAP. WHEN A NURSE ATTEMPTED TO CAP THE NEEDLE, THE NEEDLE WENT RIGHT THROUGH.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 305902, BATCH NO. 9093584. IT WAS REPORTED THAT DURING USE OF THE BD SAFETYGLIDE¿ NEEDLE THE NEEDLE WENT THROUGH THE CAP. WHEN A NURSE ATTEMPTED TO CAP THE NEEDLE, THE NEEDLE WENT RIGHT THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633621 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 9093584 30382903059028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other