BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NOKOR¿ FILTER NEEDLE

    MDR report key: 15299704 · Received August 26, 2022

    Report

    Report Number
    1911916-2022-00451
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    July 28, 2022
    Report Date
    August 31, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052004
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED ONE NEEDLE WAS FOUND TO HAVE PARTICULATE INSIDE THE CONTAINER OF THE NEEDLE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PACKAGING BLISTER WITH A NEEDLE ASSEMBLY IN IT. THERE ARE BLACK SPECKS THAT APPEAR ADHERED TO THE PACKAGING BLISTER BOTTOM WEB LOCATED TOWARDS THE BOTTOM PART OF THE NEEDLE ASSEMBLY. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305200, LOT NUMBER 1172461. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DIRT-LIKE FOREIGN MATTER WAS FOUND IN THE CAP OF THE BD NOKOR¿ FILTER NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE NEEDLE WAS FOUND TO HAVE PARTICLES / DIRT LIKE SUBSTANCE INSIDE THE CONTAINER OF THE NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DIRT-LIKE FOREIGN MATTER WAS FOUND IN THE CAP OF THE BD NOKOR¿ FILTER NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE NEEDLE WAS FOUND TO HAVE PARTICLES / DIRT LIKE SUBSTANCE INSIDE THE CONTAINER OF THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436102 BD NOKOR¿ FILTER NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 1172461 00382903052004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown