BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 7003811 · Received November 6, 2017

    Report

    Report Number
    1911916-2017-00291
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    May 19, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051069
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE TWENTY-ONE CANNULA REMOVAL FORCE TESTS WERE PERFORMED ON 105 PARTS WITH A MINIMUM REMOVAL FORCE OF 6 LBS., A MAXIMUM REMOVAL FORCE OF 23 LBS., AND AN AVERAGE OF 17.15 LBS. AN ADDITIONAL 15 CANNULA REMOVAL FORCE TESTS WERE PERFORMED ON 375 PARTS AS VERIFICATION OF THE CORONA TREATER. THE RESULTS WERE A MINIMUM REMOVAL FORCE OF 4 LBS., A MAXIMUM REMOVAL FORCE OF 21 LBS., AND AN AVERAGE OF 11.76 LBS. THE SPECIFICATION LIMITS FOR CANNULA REMOVAL FORCES FOR A 30 GAUGE NEEDLE IS A MINIMUM OF 5.0 LBS. 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 0.20%. 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 INVESTIGATION CONCLUSION: 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. SEVEN LEAK TESTS WERE PERFORMED ON 35 PARTS WITH ZERO FAILURES RECORDED. TWENTY-ONE CANNULA REMOVAL FORCE TESTS WERE PERFORMED ON 105 PARTS WITH A MINIMUM REMOVAL FORCE OF 6 LBS., A MAXIMUM REMOVAL FORCE OF 23 LBS., AND AN AVERAGE OF 17.15 LBS. AN ADDITIONAL 15 CANNULA REMOVAL FORCE TESTS WERE PERFORMED ON 375 PARTS AS VERIFICATION OF THE CORONA TREATER. THE RESULTS WERE A MINIMUM REMOVAL FORCE OF 4 LBS., A MAXIMUM REMOVAL FORCE OF 21 LBS., AND AN AVERAGE OF 11.76 LBS. THE SPECIFICATION LIMITS FOR CANNULA REMOVAL FORCES FOR A 30 GAUGE NEEDLE IS A MINIMUM OF 5.0 LBS. POSSIBLE ROOT CAUSE: 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 0.20%. INVESTIGATION RESULTS: NOT APPLICABLE ¿ NO SAMPLES OR PHOTOS WERE PROVIDED. BASED ON THE ABOVE A CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE, THAT THE NURSE FOUND LEAKAGE AFTER THE NEEDLE POPPED OFF FROM THE 30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784658 30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 4212569 00382903051069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other