BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ NEEDLE 1 IN. SINGLE USE, STERILE

    MDR report key: 13552644 · Received February 17, 2022

    Report

    Report Number
    1911916-2022-00087
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    February 7, 2022
    Report Date
    February 18, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-14. H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WAS FOREIGN MATTER IN THE PRODUCT. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WITH THE PLASTIC SHIELD AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THERE IS A BLACK SPECK IN THE NEEDLE HUB. IT WAS NOT POSSIBLE TO REMOVE THE SPECK; IT IS EMBEDDED DEGRADED RESIN. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305197, LOT NUMBER 1210583. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE MOLDING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PARTS WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    I WAS REPORTED THAT PRIOR TO USE OF A BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, THAT FOREIGN MATTER WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING NEEDLE FROM WRAPPER, THE PHARMACY TECHNICIAN NOTED DEBRIS WITHIN THE NEEDLE HUB, DID NOT USE THE PRODUCT, AND SAVED IT.

    Description of Event or Problem · 0

    I WAS REPORTED THAT PRIOR TO USE OF A BD¿ NEEDLE 1 IN. SINGLE USE, STERILE, THAT FOREIGN MATTER WAS FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING NEEDLE FROM WRAPPER, THE PHARMACY TECHNICIAN NOTED DEBRIS WITHIN THE NEEDLE HUB, DID NOT USE THE PRODUCT, AND SAVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864637 BD¿ NEEDLE 1 IN. SINGLE USE, STERILE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305197 1210583 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown