BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 7426002 · Received April 12, 2018

    Report

    Report Number
    1213809-2018-00215
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    March 27, 2018
    Report Date
    April 30, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059172
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THREE PHOTOS WERE RECEIVED AND EVALUATED. TWO APPARENTLY SEALED PACKAGED SAFETYGLIDE NEEDLES CONFIRMED TO BE FROM BATCH #7121706 (305917) WERE SEEN IN THE PHOTOS. THE PACKAGES¿ TOP WEB HAD A GREEN STRIPE WITH A LABEL THAT INDICATED PRODUCT TO BE 21X1-1/2 ON BOTH PACKAGES. ONE OF THE NEEDLE HUBS HOWEVER WAS PINK, WHICH MEANS IT WAS AN 18GA CANNULA. THE SECOND NEEDLE HUB WAS GREEN ¿ CORRECT FOR 21GA CANNULA. COMPLAINT HISTORY CHECK INDICATES THAT THIS IS THE ONLY COMPLAINT TO DATE FOR MIXED PRODUCT AGAINST THIS BATCH, INDICATING AN ISOLATED INCIDENT FOR BATCH #7121706. FURTHERMORE, 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. POTENTIAL ROOT CAUSE SCENARIOS: THE MIXED PRODUCT LIKELY OCCURRED DUE TO A POOR LINE CLEARANCE. BASED ON THE INVESTIGATION AND THE INFORMATION THAT WE KNOW TODAY, WE CAN CONCLUDE THAT IT IS POSSIBLE FOR A FEW 18GA NEEDLES FROM THE PREVIOUS BATCH TO NOT HAVE BEEN CLEARED FROM THE LINE AND ENDED UP GETTING MIXED IN WITH THE COMPLAINT BATCH. NO CONTAINMENT ACTION IS RECOMMENDED SINCE THE PROBABLE ROOT CAUSE IDENTIFIED POOR LINE CLEARANCE POTENTIALLY IMPACTING ONLY A FEW PIECES IN THE ENTIRE BATCH #7121706 (P/N 305917). 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

    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

    IT WAS REPORTED THAT MIXED PRODUCT (PRODUCT WITH A ¿PINK CAP¿) WAS PACKAGED IN THE 21 G X 1 1/2 IN. BD SAFETYGLIDE¿ NEEDLE PACKAGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267400 BD SAFETYGLIDE¿ NEEDLE NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7121706 30382903059172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other