BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 11593123 · Received March 30, 2021

    Report

    Report Number
    1911916-2021-00262
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 4, 2021
    Report Date
    March 24, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: IT WAS REPORTED THAT THERE WAS A PARTICLE (> 1MM) THAT ADHERED TO THE CANNULA. TO AID IN THE INVESTIGATION, ONE SAMPLE AND ONE PHOTO WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE CAME WITH THE PLASTIC SHIELD, BUT NO PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED AND THE SAMPLE HAS A THIN PIECE OF PLASTIC ADHERED TO THE NEEDLE ABOUT 1/8" FROM THE NEEDLE TIP. THE PHOTO PROVIDED SHOWS A NEEDLE WITH NO PLASTIC SHIELD. THE NEEDLE HAS A FOREIGN MATTER ADHERED TOWARDS THE NEEDLE TIP. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR WHEN DURING PREVENTATIVE MAINTENANCE OR CLEANING A PARTICLE BECAME LOOSE. WHEN PRODUCTION WAS RESTARTED THE PARTICLE ENDED UP ON THE NEEDLE. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE AND RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. IN ORDER TO HELP ALLEVIATE THIS DEFECT, VERIFICATION OF CLEANLINESS IN THE LINE AFTER PREVENTATIVE MAINTENANCE NOW INCLUDES VERIFICATION OF A REVIEWER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT 8250854. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A "> 1MM" FOREIGN PARTICLE WAS FOUND ON THE CANNULA OF THE BD¿ BLUNT FILL NEEDLE WITH FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE REASON FOR THE COMPLAINT WAS A PARTICLE (> 1MM) THAT ADHERED TO THE CANNULA. THE FILTER NEEDLE COULD THEREFORE NOT BE USED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489116 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 8250854 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1