BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NOKOR¿ FILTER NEEDLE

    MDR report key: 9087016 · Received September 19, 2019

    Report

    Report Number
    1911916-2019-00985
    Event Type
    Malfunction
    Date Received
    September 19, 2019
    Date of Event
    August 13, 2019
    Report Date
    September 25, 2019
    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 · 0

    H.6. INVESTIGATION: ONE (1) SAMPLE AND TWO (2) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLE WAS VISUALLY EXAMINED USING UNAIDED VISION AND IT WAS OBSERVED THAT THE NEEDLE HUB HAS EPOXY DRIP OVER ON THE OUTSIDE OF THE NEEDLE HUB. TWO (2) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ONE (1) PHOTO SHOWS THE SHIELDED NEEDLE ASSEMBLY AGAINST A BLUE BACKGROUND. THERE IS A WHITE SUBSTANCE ON THE NEEDLE HUB ASSEMBLY. THE SECOND (2ND) PHOTO SHOWS THE BLISTER PACK AGAINST THE BLUE BACKGROUND VIEWED FROM THE BOTTOM WEB. THIS PHOTO PROVIDES THE LOT NUMBER OF THE BATCH ASSOCIATED WITH THIS COMPLAINT. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEW DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. POSSIBLE ROOT CAUSE, EPOXY IS USED IN ADHERING THE CANNULA TO THE NEEDLE HUB AND IS PART OF THE NORMAL PRODUCTION PROCESS. VISUAL INSPECTION OF THE PHOTOS PROVIDED BY THE CUSTOMER IDENTIFIED THAT THE WHITE FOREIGN MATTER REPORTED BY THE CUSTOMER AS EPOXY DRIP OVER ON THE NEEDLE. AN EPOXY DRIP OVER GENERALLY OCCURS WHEN THE EPOXY APPLICATOR FAILS TO SHUT OFF FOR A MISSING CANNULA. THERE ARE SEVERAL CONTRIBUTING / POSSIBLE FACTORS. A DIRTY SENSOR THAT DOES NOT SHUT THE EPOXY OFF FOR A MISSING CANNULA THE EPOXY PRESSURE IS TOO HIGH. THE EPOXY APPLICATOR NEEDS ATTENTION ¿ IT IS NOT SHUTTING OFF WHEN IT SHOULD. THE EPOXY VISCOSITY IS ALSO RELATED TO TEMPERATURE FLUCTUATIONS. IF THE TEMPERATURE GOES UP, THE EPOXY GETS THINNER AND FLOWS FASTER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    MATERIAL NO. 305200; BATCH NO. 8200529. IT WAS REPORTED THAT BEFORE USE OF THE BD NOKOR¿ FILTER NEEDLE THE FILTER NEEDLE CONTAINED A WHITE SUBSTANCE COVERING A PORTION OF THE FILTER NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTER STATED THAT THE PHYSICIAN NOTED ON (B)(6) 2019, THAT THE FILTER NEEDLE CONTAINED A WHITE SUBSTANCE COVERING A PORTION OF THE FILTER NEEDLE HUB. THE PHYSICIAN DISCOVERED THE ISSUE UPON OPENING THE PACKAGING FOR THE FILTER NEEDLE, THEREFORE THE DAMAGE WAS NOTED WHEN THE PHYSICIAN OPENED THE PACKAGING OF THE FILTER NEEDLE PER THE PC QUESTIONNAIRE. THE REPORTER STATED THAT THE WHITE SUBSTANCE "LOOKS LIKE PAINT" AND THAT IT "LOOKS LIKE SOMETHING SPLASHED ONTO THE TOP OF THE HUB". THE PHYSICIAN USED THE OFFICE'S OWN FILTER NEEDLE SUPPLY TO PROVIDE THE INJECTION TO THE PATIENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MATERIAL NO. 305200 BATCH NO. 8200529. IT WAS REPORTED THAT BEFORE USE OF THE BD NOKOR¿ FILTER NEEDLE THE FILTER NEEDLE CONTAINED A WHITE SUBSTANCE COVERING A PORTION OF THE FILTER NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE REPORTER STATED THAT THE PHYSICIAN NOTED ON 13-AUG-2019, THAT THE FILTER NEEDLE CONTAINED A WHITE SUBSTANCE COVERING A PORTION OF THE FILTER NEEDLE HUB. THE PHYSICIAN DISCOVERED THE ISSUE UPON OPENING THE PACKAGING FOR THE FILTER NEEDLE, THEREFORE THE DAMAGE WAS NOTED WHEN THE PHYSICIAN OPENED THE PACKAGING OF THE FILTER NEEDLE PER THE PC QUESTIONNAIRE. THE REPORTER STATED THAT THE WHITE SUBSTANCE "LOOKS LIKE PAINT" AND THAT IT "LOOKS LIKE SOMETHING SPLASHED ONTO THE TOP OF THE HUB". THE PHYSICIAN USED THE OFFICE'S OWN FILTER NEEDLE SUPPLY TO PROVIDE THE INJECTION TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889775 BD NOKOR¿ FILTER NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8200529 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other