BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 7060306 · Received November 27, 2017

    Report

    Report Number
    1911916-2017-00306
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    May 19, 2017
    Report Date
    December 11, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR INVESTIGATION. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. DHR REVIEW: ASSEMBLY BATCH 4181738 HAD 79 VISUAL INSPECTIONS PERFORMED ON 4,100 PARTS WITH ZERO DEFECTS NOTED. LEAK AND FORCE TESTS WERE PERFORMED WITH ZERO FAILURES RECORDED. THERE WAS ONE LOW CANNULA REMOVAL FORCE OF 4.0 LBS. RECORDED. A TOTAL OF 480 PARTS WERE TESTED FOR CANNULA REMOVAL AND ONE FAILURE IS A DEFECT RATE OF (B)(4). INVESTIGATION CONCLUSION: THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS 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 ROOT CAUSE DESCRIPTION: THERE WAS ONE LOW CANNULA REMOVAL FORCE OF 4.0 LBS. RECORDED. THE AQL FOR CANNULA REMOVAL FORCE IS 0.65%. WE TESTED 480 PARTS FOR CANNULA REMOVAL AND ONE FAILURE IS A DEFECT RATE OF (B)(4). WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DRAWING UP MEDICATION, THE NEEDLE ON A BD PRECISIONGLIDE" SPECIALTY USE STERILE HYPODERMIC NEEDLE, THE NEEDLE DETACHED LEAKING THE MEDICATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839017 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC SYRINGE WITH NEEDLE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 4212569 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other