BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NOKOR¿ FILTER NEEDLE

    MDR report key: 7880821 · Received September 17, 2018

    Report

    Report Number
    1911916-2018-00502
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 26, 2018
    Report Date
    August 28, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052005
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: THERE WAS NO ACTUAL RETURNED SAMPLE OR PHOTO PROVIDED FOR EVALUATION. WITHOUT AN ACTUAL SAMPLE IN THIS SPECIFIC CASE, IT¿S NOT POSSIBLE TO DETERMINE ORIGIN OF THE FOREIGN MATTER. IN ORDER FOR FOREIGN MATTER TO ENTER THE SYRINGE FROM THE FILTER NEEDLE (SINCE THERE IS A 5MICRON FILTER WITHIN THE HUB), FOREIGN MATTER WOULD HAVE TO BE PRESENT IN THE LUER OF THE HUB. THE HUBS ARE MOLDED BY AN OUTSIDE VENDOR AND SHIPPED WITHIN A PLASTIC LINER. AN INCOMING INSPECTION IS PERFORMED ON EACH BATCH RECEIVED. THE HUBS ARE COMPLETELY COVERED WHEN THEY ARE TRANSFERRED TO THE ASSEMBLY PROCESS WHERE THEY ARE PLACED INTO A COVERED HOPPER. THEY¿RE FED DIRECTLY FROM THE HOPPER ONTO INDIVIDUAL RACK PINS (THE LUER OF THE HUB SETS ON THE RACK PIN) UNTIL THE ASSEMBLY PROCESS IS COMPLETE. THE FULL NEEDLE ASSEMBLY IS THEN STRIPPED FROM THE RACK AND AIR-VEYED INTO A PLASTIC LINER OR COVERED BULK TANK. THE PLASTIC LINER AND/OR BULK TANK IS TRANSFERRED TO THE PACKAGING PROCESS WHERE THE PARTS ARE FED DIRECTLY INTO THE PACKAGING HOPPER/FEEDER TRAY. THE NEEDLE ASSEMBLY IS TRANSFERRED TO THE UNIT PACKAGE AND SEALED. THE PROCESS IS DESIGNED TO HAVE MINIMAL EXPOSURE TO THE ENVIRONMENT. INVESTIGATION CONCLUSION: THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT #7020612 REGARDING ITEM #305200. BATCH 7020612 WAS PACKAGED ON MULTIVAC LINE 4 FOR A QUANTITY OF 360,000 ON ONE SHIFT 1/23/2017. THE CLEANING WAS PERFORMED AS REQUIRED. ASSEMBLY BATCH 6300802 FED INTO PACKAGE BATCH 7020612. ASSEMBLY BATCH 6300802 WAS PRODUCED ON NIP LINE 7 FOR A QUANTITY OF 2,184,000 ON 1/18/2017 ¿ 1/20/2017. THERE WERE 50 VISUAL INSPECTIONS PERFORMED ON 2,500 PARTS WITH ZERO DEFECTS NOTED. SHIFT CLEANING WAS PERFORMED 7 TIMES THROUGHOUT THE PRODUCTION RUN. ROOT CAUSE DESCRIPTION: UNDETERMINED. RATIONALE: NO SAMPLE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NOKOR¿ FILTER NEEDLE CONTAINED FOREIGN MATTER DESCRIBED AS "BLACK SPECK". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722943 BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 7020612 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other