BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7097833 · Received December 7, 2017

    Report

    Report Number
    1213809-2017-00328
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 13, 2017
    Report Date
    December 18, 2017
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS. THREE SEALED SAFETY GLIDE PACKAGED NEEDLES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #5111979. THE SAMPLES WERE EVALUATED. NO VISUAL DEFECTS WERE OBSERVED. THE NEEDLES WERE REMOVED FROM THE PACKAGING AND THE LENGTH OF EACH NEEDLE CANNULA WAS MEASURED. THE LENGTH OF ALL SAMPLES WAS CONFIRMED TO BE WITHIN SPECIFICATION FOR A 1¿ NEEDLE PRODUCT. THE NEEDLE SHIELD USED WAS ALSO CORRECT FOR THE 1¿ NEEDLE PRODUCT AND WOULD NOT BE ABLE TO EASILY CONTAIN A LONGER NEEDLE. PLEASE NOTE THAT THE NEEDLE LENGTH IN PRODUCT DESCRIPTION REFERS TO INJECTABLE NEEDLE LENGTH BEFORE THE SAFETY GLIDE FEATURE IS ACTIVATED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5111979. CONCLUSION: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE.

    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 THE PACKAGING OF A BD SAFETYGLIDE¿ NEEDLE WAS LABELED AS A 1¿ NEEDLES BUT WERE CLOSER TO 1 ½¿ NEEDLES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877903 BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 5111979 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other