BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7100524 · Received December 8, 2017

    Report

    Report Number
    1213809-2017-00335
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    November 15, 2017
    Report Date
    February 6, 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
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: ONE OPEN SHELF CARTON OF 33 SEALED SAFETY GLIDE NEEDLES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #6001842 (P/N 305916). THE SAMPLES WERE VISUALLY EVALUATED. THE PRODUCT IS LABELED AS 1¿ NEEDLE. THE SEALED NEEDLE SAMPLES CONTAINED 5/8" NEEDLES. THIS COMPLAINT IS CONFIRMED TO BE WITHIN THE SCOPE OF A KNOWN ISSUE. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS FAILURE MODE. CAPA (B)(4) WAS OPENED TO ADDRESS THIS ISSUE. NO FURTHER ACTION IS REQUIRED AT THIS TIME. CONCLUSION: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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.

    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 THE PACKAGING ON A BD SAFETYGLIDE¿ NEEDLE WAS MARKED AS 1" BUT HAD 5/8" NEEDLES INSIDE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880309 BD SAFETYGLIDE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 6001842 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other