BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE

    MDR report key: 6746107 · Received July 27, 2017

    Report

    Report Number
    1911916-2017-00093
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    February 7, 2017
    Report Date
    November 15, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. DHR REVIEW: ASSEMBLY BATCH 4181680 HAD 77 VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH NO DEFECTS NOTED. THE ID INSPECTION SYSTEM WAS CHALLENGED 38 TIMES USING (B)(4) PARTS WITH ZERO FAILURES RECORDED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: DATE RECEIVED BY MANUFACTURER: 06/06/2017. INVESTIGATION: RESULTS: NO SAMPLE OR PHOTO PROVIDED NEW INFORMATION. THIRTY-NINE SHIELD REMOVAL FORCE TESTS WERE PERFORMED ON 195 PARTS WITH A MINIMUM REMOVAL FORCE OF 2.1 LBS., A MAXIMUM REMOVAL FORCE OF 5.7 LBS., AND AN AVERAGE OF 3.49 LBS. THE SPECIFICATION LIMITS ARE 0.5 ¿ 12.0 LBS. WITH AN AVERAGE < 9.0 LBS. TWENTY CANNULA REMOVAL FORCE TESTS WERE PERFORMED ON 100 PARTS WITH A MINIMUM REMOVAL FORCE OF 18 LBS., A MAXIMUM REMOVAL FORCE OF 40 LBS., AND AN AVERAGE OF 27.8 LBS. THE SPECIFICATION LIMIT FOR A 19 GAUGE NEEDLE IS A MINIMUM REMOVAL FORCE OF 16 LBS. ROOT CAUSE: BASED ON THE INVESTIGATION CONCLUSION, BD MPS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP AND NEEDLE POPPED OFF OF A 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528827 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 4181650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other